Annual technical report 2015: department of reproductive health and research, including UNDP/UNFPA/WHO/World Bank Special Programme of Research Training in Human Reproduction (HRP)
Publication date: 2016
2015 For more information, please contact: Department of Reproductive Health and Research World Health Organization Avenue Appia 20, CH-1211 Geneva 27, Switzerland Fax: +41 22 791 4171 E-mail: email@example.com www.who.int/reproductivehealth Annual technical report 2015 Department of Reproductive Health and Research UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) Department of Reproductive Health and Research, including the UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP) Annual Technical Report, 2015 WHO/RHR/HRP/16.08 UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP). Annual Technical Report 2015 © World Health Organization 2016 All rights reserved. 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Editing: Green Ink (www.greenink.co.uk) Layout: Oceans Translations (www.oceanstranslations.com) Cover photo: Harsha KR licensed under CC by 2.0 Printed by the WHO Document Production Services, Geneva, Switzerland Table of contents Acronyms and abbreviations v 1. Introduction 1 2. High-level advocacy and input to global initiatives for sexual and reproductive health 3 3. Thematic areas 15 3.1 Family planning and contraception 15 3.2 Adolescent sexual and reproductive health 34 3.3 Maternal and perinatal health 48 3.4 Preventing unsafe abortion 87 3.5 Sexually transmitted infections and reproductive tract infections; SRH–HIV linkages and multipurpose prevention technologies 100 3.6 Cervical cancer 117 3.7 Violence against women and harmful practices, including female genital mutilation and early marriage 124 3.8 Sexual and reproductive health in humanitarian settings 135 3.9 Infertility 141 3.10 Sexual Health 146 4. Cross-cutting topics 151 4.1 Human rights and gender equality 151 4.2 Innovations 154 4.3 Biostatistics and data management 161 4.4 Advocacy and communications 166 4.5 Research project review through RP2 176 5. Research capacity strengthening, including the HRP Alliance 179 Annex A. HRP results report 2014–2015 (provisional expenditure data) 188 Annex B. Indicator report 212 Annex C. Donors 2014-2015 242 Acronyms and abbreviations v ACS antenatal corticosteroids AGH Adolescents and at-Risk Populations (team within RHR/HRP) AHEAD Adolescent Health Experience after Abortion or Delivery (trial) ALIRH Latin American Association of Researchers in Human Reproduction AMR antimicrobial resistance ANC antenatal care ARMADILLO Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes ARV antiretroviral ASRH adolescent sexual and reproductive health ASRM American Society for Reproductive Medicine AST antimicrobial susceptibility testing BOLD Better Outcomes in Labour Difficulty (project) BSC brief sexuality-related communication CDC United States Centers for Disease Control and Prevention CEFM child, early and forced marriage CEPEP The Centre for Population Studies, Asunción, Paraguay CERCA Community-embedded reproductive health care for adolescents (project) CERQual Confidence in the Evidence from Reviews of Qualitative research tool CESCR Committee on Economic, Social and Cultural Rights CIDES-UMSA The Centre for Research in Development Sciences of San Andrés University, La Paz, Bolivia CIRE Continuous Identification of Research Evidence CoIA Commission on Information and Accountability for Women’s and Children’s Health CONSORT Consolidated Standards of Reporting Trials CRVS civil registration and vital statistics DECIDE Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence framework DHS Demographic and Health Survey DMPA depot medroxyprogesterone acetate DSMB Data Safety and Monitoring Board EBOV Ebola virus EC emergency contraception ECOWAS Economic Community of West African States EMTCT elimination of mother-to-child transmission EPMM Ending Preventable Maternal Mortality (strategy) ERC see WHO-ERC Acronyms and abbreviations Annual Technical Report 2015vi EtD Evidence to Decision (framework) EVD Ebola virus disease FGM female genital mutilation FIGO International Federation of Gynecology and Obstetrics FP2020 Family Planning 2020 (an outcome of the 2012 London Summit on Family Planning) GAP gentle assisted pushing GAPP Global Abortion Policies Project GARPR Global AIDS Response Progress Reporting System GASP Gonococcal Antimicrobial Surveillance Programme Gavi Gavi – The Vaccine Alliance (formerly the Global Alliance for Vaccines and Immunization) GBV gender-based violence GDG Guideline Development Group GEAS Global Early Adolescent Study GFF Global Financing Facility GIZ Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH GLASS Global AMR Surveillance System GRADE Grading Recommendations, Assessment, Development and Evaluation GREAT Network Guideline-driven, Research priorities, Evidence synthesis, Application of evidence, and Transfer of knowledge GRC Guidelines Review Committee GVAC Global Validation Advisory Committee H4+ UNFPA, UNICEF, WHO, The World Bank, UNAIDS, UN Women HPV human papillomavirus HRP UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction; also: Human Reproduction Programme HSV herpes simplex virus IAEA International Atomic Energy Agency IARC International Agency for Research on Cancer IAS International AIDS Society IBP Implementing Best Practices ICD International Statistical Classification of Diseases and Related Health Problems ICD-MM WHO Application of ICD-10 to deaths during pregnancy, childbirth and the puerperium (ICD-Maternal Mortality) ICD-PM WHO Application of ICD-10 to perinatal deaths (ICD-Perinatal Mortality) ICFP International Conference on Family Planning ICPD International Conference on Population and Development ICT information and communication technology IEC information, education and communication iEtD interactive Evidence-to-Decision (tool) Acronyms and abbreviations vii IFFS International Federation of Fertility Societies IMPT Initiative for Multipurpose Prevention Technologies INGO international nongovernmental organization IPPF International Planned Parenthood Federation IPU Inter-Parliamentary Union IRB Institutional Review Board IRP Implementation Research Platform IUD intrauterine device IVB Immunization, Vaccines and Biologicals (WHO Department) IWG Innovation Working Group KG Knowledge Gateway LBC liquid-based cytology LID Long-term Institutional Development (grant) LMIC low- and middle-income countries LNG levonorgestrel M&E monitoring and evaluation MAPS mHealth for Assessment and Planning for Scale (toolkit) MCA Maternal, Newborn, Child and Adolescent Health (WHO Department) MCS multicountry survey MDG Millennium Development Goal MEC Medical eligibility criteria for contraceptive use MHTF Maternal Health Task Force MISP Minimum Initial Service Package MMEIG Maternal Mortality Estimation Interagency Group MMWG Maternal Morbidity Working Group MOH ministry of health MPA medroxyprogesterone acetate MPT multipurpose prevention technology MSI Marie Stopes International MSM men who have sex with men mTERG Technical and Evidence Review Group on mHealth for RMNCH NET-EN norethisterone enanthate NGO nongovernmental organization NIH United States National Institutes of Health NVI Noncommunicable Diseases, Disability, Violence and Injury Prevention (WHO Department) OCHA United Nations Office for the Coordination of Humanitarian Affairs OpenSRP Open Smart Register Platform PAC Project Advisory Committee PAHO Pan American Health Organization PCC Policy and Coordination Committee Annual Technical Report 2015viii PICO population, intervention, comparator and outcome PLISSER Latin American Program of Research in Sexual and Reproductive Health PMTCT prevention of mother-to-child transmission POCT point-of-care test PPFP postpartum family planning PrEP pre-exposure prophylaxis PRS Programme Reporting Standards PSI Population Services International RCS research capacity-strengthening RCT randomized controlled trial RDT rapid diagnostic test RHL Reproductive Health Library RHR Reproductive Health and Research (WHO Department) RMNCAH reproductive, maternal, newborn, child and adolescent health RMNCH reproductive, maternal, newborn and child health RP2 Research Project Review Panel RRC Regional Research Committee RT-PCR reverse transcription polymerase chain reaction RTS room temperature stable SAWG Scientific Advisory Working Group SBA skilled birth attendance/attendant SDG Sustainable Development Goal SELMA Simplified, Effective, Labour Monitoring-to-Action tool SRH sexual and reproductive health SRHR sexual and reproductive health and rights SPR Selected practice recommendations for contraceptive use STAG Scientific and Technical Advisory Group STI sexually transmitted infection SVRI Sexual Violence Research Initiative TAG Technical Advisory Group TAG Topic Advisory Group TDR Special Programme for Research and Training in Tropical Diseases (hosted at WHO) TMB treaty monitoring body TRP Training Resource Package for Family Planning TU testosterone undecanoate UN United Nations UNAIDS Joint United Nations Programme on HIV and AIDS UNESCO United Nations Educational, Scientific and Cultural Organization UNFPA United Nations Population Fund UNHCR United Nations High Commissioner for Human Rights UNICEF United Nations Children’s Programme Acronyms and abbreviations ix UNODC United Nations Office on Drugs and Crime UNPD United Nations Population Division USAID United States Agency for International Development VIA visual inspection of the cervix with acetic acid VSU victim support unit WAHO West African Health Organisation WFP World Food Programme WHO World Health Organization WHO-ERC WHO Ethics Review Committee TAG Technical Advisory Group TAG Topic Advisory Group TDR Special Programme for Research and Training in Tropical Diseases (hosted at WHO) TMB treaty monitoring body TPP Target Product Profiles TRP Technical Review Panel TRP Training Resource Package for Family Planning TRT Technical Resource Team TT tetanus toxoid TU testosterone undecanoate UHC universal health coverage UICC Union Internationale Contre le Cancer UN United Nations UNAIDS Joint United Nations Programme on HIV and AIDS UNESCO United Nations Educational, Scientific and Cultural Organization UNFPA United Nations Population Fund UNICEF United Nations Children’s Programme UNODC United Nations Office on Drugs and Crime UNPD United Nations Population Division USAID United States Agency for International Development VIA visual inspection of the cervix with acetic acid WAHO West African Health Organisation WHA World Health Assembly WHO World Health Organization WHOCC WHO Collaborating Centre WHO-ERC WHO-Ethics Review Committee Annual Technical Report 2015x Introduction 1 1. Introduction The UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction, also known as the Human Reproduction Programme (HRP), is the main instrument and leading research agency within the United Nations (UN) system concerned with sexual and reproductive health and rights. The World Health Organization (WHO) serves as the executing agency for HRP, which is housed within, and forms part of, the WHO Department of Reproductive Health and Research (RHR). Universal access to sexual and reproductive health and rights is now globally recognized as crucial for improving the health and well-being of populations as well as making progress towards the achievement of worldwide aims and targets.These include the new Sustainable Development Goals (SDGs; 2016–2030), launched in 2015, the preceding Millennium Development Goals (MDGs; 2000–2015), the aims of the Programme of Action of the International Conference on Population and Development (ICPD, 1994) as well as the UN Secretary-General’s Every Woman Every Child (EWEC) movement, in particular the new Global Strategy for Women’s, Children’s and Adolescents’ Health, whichwas also launched in 2015. The collective vision represented by these global goals and strategies, which has been formed by agreement within and across countries and regions including by the world’s leading institutions dedicated to sustainable development, underlines the critical importance of the work of the Department, which aims to promote universal access to sexual and reproductive health. HRP was established in 1972, and continues to support and coordinate research on a global scale; to synthesize research through systematic reviews of literature; to build research capacity in low-income countries; and to develop dissemination tools to make efficient use of an ever-increasing body of research and information. By virtue of its unique co-sponsoring arrangement, the work of HRP is coordinated with, and contributes to, the work of its co-sponsors and partners including the United Nations Development Programme (UNDP), the United Nations Population Fund (UNFPA), the United Nations Children’s Fund (UNICEF), WHO, The World Bank, the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the International Planned Parenthood Federation (IPPF). The year 2015 has been an important year for the Department to further build upon the strength of its work, including on priorities such as family planning, maternal health and adolescent sexual and reproductive health. The Department continues also to strengthen its commitment to a human-rights-based approach, as well as taking a global lead on critical issues. The achievements made by the Department across its thematic areas are here united in this report. This document also underlines the urgency of work to be done collaboratively, to make crucial progress towards improving sexual and reproductive health and rights for people worldwide. Annual Technical Report 20152 High-level advocacy and input to global initiatives for sexual and reproductive health 3 2. High-level advocacy and input to global initiatives for sexual and reproductive health 2.1 Introduction The WHO Department of Reproductive Health and Research, including HRP, has engaged in a range of global advocacy activities to promote sexual and reproductive health (SRH) in the context of regional and global initiatives. This includes the development of the renewed Global Strategy for Women’s, Children’s and Adolescents’ Health launched alongside the new SDG agenda. The Department has led the development of a global plan of action to strengthen the role of the health system within a national multisectoral response to address interpersonal violence, in particular against women and girls, and against children, and also of the Global Health Sector Strategies for HIV, viral hepatitis and sexually transmitted infections, 2016–2021. These initiatives will be elaborated under the thematic sections of this report (see section 126.96.36.199 and section 188.8.131.52, respectively). The Department has also continued its engagement with other initiatives including Family Planning 2020 (FP2020), the Sexual Violence Research Initiative (SVRI), Ending Preventable Maternal Mortality (EPMM), the International Conference on Population and Development (ICPD)Geneva Network of Member States, and the Global Fund to Fight AIDS, Tuberculosis and Malaria. Work completed during 2015 has also been instrumental in consolidating the Department’s efforts to engage with political stakeholders, including parliaments and parliamentarians, on issues related to sexual and reproductive health and rights. The Department engaged in global and regional processes for the advancement of sexual and reproductive health and rights (SRHR) and for strengthening of normative standards in this regard. In particular, the Department led the technical work-stream on human rights and the Global Strategy for Women’s and Children’s Health; released a ground-breaking report on Sexual health, human rights and the law; led the publication of a special supplementto The BMJentitled “Towards a new Global Strategy for Women’s, Children’s and Adolescents’ Health”, and a special supplement tothe Journal of the International AIDS Societyentitled“Sexual and reproductive health and human rights of women living with HIV”. Furthermore, the Department published several papers on different dimensions of human rights as they relate to SRH. The Department continued to develop new tools and guidance on human rights in relation to family planning, safe abortion, mistreatment and abuse, and female genital mutilation (FGM). Major achievements • The Global Strategy for Women’s, Children’s and Adolescents’ Health was launched at theUN General Assembly, 26 September 2015, in New York. • A draft was developed of the global plan of action to strengthen the role of the health system within a national multisectoral response to address interpersonal violence, in particular against women and girls, and against children. • The draft Global Health Sector Strategy on sexually transmitted infections, 2016–2021, was completed. • A special supplement to The BMJ was issued, entitled “Towards a new Global Strategy for Women’s, Children’s and Adolescents’Health”. Annual Technical Report 20154 • A report of a study on child, early and forced marriage (CEFM) legislation in the Asia- Pacific region was developed in collaboration with the Inter-Parliamentary Union (IPU). • The WHO Statement on caesarean section rates was published, superseding the earlier 1985 statement, which is widely quoted. The new Statement emphasized that while there seem to be mortality benefits up to national population level rates of 10%, much of the association can be explained by the development status of the country. • Estimates of maternal mortality 1990–2015 were published, both as a paper in The Lancet and as a full interagency report.It is estimated that 303 000 maternal deaths will occur in 2015 and there has been a 44% decline in the maternal mortality ratio since 1990; falling short of the MDG goal. • The Department published the WHO framework on quality of care for pregnant women and newborns around the time of childbirth (Quality of care for pregnant women and newborns – the WHO vision, published in BJOG). The quality statements and indicators for the eight domains focusing on both provision and experience of care were finalized. 2.2 Contribution to global initiatives and follow up of the commitments 2.2.1 The Global Strategy for Women’s, Children’s and Adolescents’ Health –the Every Woman Every Child movement and the accountability framework Progress Within the context of the Every Woman Every Child (EWEC) globalmovement and the new sustainable development agenda, the Department has played a key role in the process of development of the renewed Global Strategy for Women’s, Children’s and Adolescents’ Health(1). The EWEC is an unprecedented global movement that continuously mobilizes international and national action by governments, the UN, multilaterals, the private sector and civil society to address the major health challenges facing women, children and adolescents; this year EWEC has put the new Global Strategy into action. The new Global Strategy (2016–2030) is a roadmap to achieve the highest attainable standard of health for all women, children and adolescents –to transform the future and ensure that every newborn, mother and child not only survives, but thrives. The new Global Strategy builds on the success of the previous Global Strategy launched in 2010 and its EWEC movement, a platform to accelerate the health-related Millennium Development Goals,which now puts women, children and adolescents at the heart of the new UN SDGs. The new Global Strategy was launched at the 2015 UN General Assembly where UNSecretary-GeneralBan Ki-moon announced over $25 billion in initial commitments spanning five years to help end preventable deaths of women, children and adolescents, and ensure their health and well-being. Heads of state and governments, international organizations, the private sector, foundations, civil society, research and academic institutions, and other key partners joined the event during the UN Sustainable Development Summit for the adoption of the post-2015 development agenda (convened as a high-level plenary meeting of the General Assembly) to pledge their support to the Global Strategy for Women’s, Children’s and Adolescents’ Health. The new Global Strategy has been developed through an extensive consultation process involving governments, civil society, the private sector, UN agencies and other constituencies. The Department played a central role in the development of the Global Strategy and was High-level advocacy and input to global initiatives for sexual and reproductive health 5 actively engaged in the preparation of the consultations held in 2014–2015,first in Geneva, followed by New Delhi and Johannesburg. More than 7000 individuals, organizations and government representatives participated in the consultations during the World Health Assembly, through face-to-face and online consultations, as well as through the development of evidence-based background papers. Together with the support to the process of consultations on the Global Strategy, theDepartment led the development of a special supplement to The BMJ,“Towards a new Global Strategy for Women’s, Children’s and Adolescents’Health”(2). Launched at the 2015 UN General Assembly in New York, the special supplement consists of 15 papers that are the foundation of the Global Strategy. The papers, developed by a large and diverse range of global experts, pull together the latest evidence on“what works” to improve the health and save the lives of women, children and adolescents, particularly in low-resource settings. The 15 papers, co-authored by WHO and led by the Department, outline the current evidence and identify successes and critical gaps in progress, and also highlight key priorities to end preventable deaths and build resilient and prosperous societies. They provide evidence that has helped inform the development of the new Global Strategy. The 15 papers’ findings underscore how persistent inequalities within and between countries mean that the poorest, most disadvantaged women, children and adolescents often miss out on life-saving health services and experience serious violations of their human rights. The papers clearly highlight that “business as usual” will not work. For women, children and adolescents around the world to survive, thrive and transform, we need actions that will result in enormous social, demographic and economic benefits. A critical part of this new Global Strategy for Women’s, Children’s and Adolescents’ Health was the creation of an accountability mechanism to ensure that commitments to women’s and children’s health were being delivered on time and making an impact. As part of the Global Strategy, the UN Secretary-General called for the establishment of a process to ensure global reporting, oversight and accountability. In this context, in 2015 theDepartment supported the preparation of the Stakeholders’Meeting on Accountability for Women’s, Children’s and Adolescents’ Health, held in Geneva on 16–17 November.The original members of the Commission on Information and Accountability (CoIA) and its independent Expert Review Group (iERG) members, and some 100 senior representatives from governments, parliaments, civil society, international organizations and the private sector met to operationalize the new accountability framework of the Global Strategy. Planned activities • In 2016, the Department will contribute to the operationalization of the Global Strategy for Women’s, Children’s and Adolescents’ Health in alignment with the post- 2015 sustainable development agenda.Countries will lead the implementation of the Global Strategy guided by their own country plans, with support from WHO and other partners. Significant attention will be paid (i) to building the capacities of health systems so that they are resilient, efficient and effective, and (ii) to promoting multistakeholder partnerships that go beyond the health sector. • In 2016, the Department will contribute to the development of an accountability framework for the new Global Strategy, including the prioritization of indicators and proposed processes foraction, monitoring and review. Additionally, the department will lead on SRH related sections of an annual report of progress in implementation of the Global Strategy, analysing and reporting on the prioritized indicators. Annual Technical Report 20156 • The Department will develop framework for its work on humanitarian settings extending over crosscutting activities addressing reproductive, maternal and perinatal health, abortion, family planning, sexual health, and gender-based violence for populations affected by humanitarian crises and fragile settings. So far we have conducted a scoping review of SRH interventions in humanitarian and fragile settings between 2005 and 2015 that has informed the development of the framework by identifying gaps and research opportunities. Priority areas for the RHR Department are currently under development. • Building onto the operational framework of the new UN Global Strategy for Women’s, Children’s and Adolescents’ Health, the Department is identifying priorities on monitoring and evaluation for SRH in humanitarian crises and fragile settings. This will bring together UN agencies (e.g. UNICEF, the UN Office for the Coordination of Humanitarian Affairs, and the UN High Commissioner for Refugees) and governmental bodies (e.g. the United States Centers for Disease Control and Prevention), as well as nongovernmental organizations and project implementers, designers and architects to disseminate knowledge on available and current innovations for humanitarian settings. 2.2.2 Sustainable Development Goals Progress At the 2015 UN General Assembly, more than 150 world leaders gathered together to adopt the ambitious new sustainable development agenda. The new agenda – Transforming our world: the 2030 agenda for sustainable development– was agreed by the 193 Member States of the UN and consists of a Declaration, 17 SDGs and 169 targets (3). Among the 17 SDGs, Goal 3 covers health: Ensure healthy lives and promote well-being for all at all ages. Targets related to sexual and reproductive health (SRH) include: target 3.1: “By 2030, reduce the global maternal mortality ratio to less than 70 per 100 000 live births” and target 3.7: “By 2030, ensure universal access to sexual and reproductive health-care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programmes”. SDG 5 (Achieve gender equality and empower all women and girls) is also relevant to health, especially target 5.6: “Ensure universal access to sexual and reproductive health and reproductive rights as agreed in accordance with the Programme of Action of the International Conference on Population and Development and the Beijing Platform for Action and the outcome documents of their review conferences”. The Department has been actively engaged in the promotion of anSRH-related SDG, acting as a prominent focal point for SRHR within the global community during the SDGs negotiations. A consultative process was conducted to devise a list of indicator recommendationsrelating specifically to SRHR; this processinvolved a wide range of stakeholders and technical experts, including experts from the Department. Additionally, SDG Goal 5 (Achieve gender equality and empower all women and girls) includes relevant SRH targets and proposed indicators on violence against women, female genital mutilation, early marriage and reproductive rights. Although the SDGs are comprehensive, visionary and inspiring in many ways, the scope of SRHR issues they address is limited, and the SDG indicators are not likely to include certain critically important elements of SRHR.To address these potential gaps, the Guttmacher Institute and The Lancet established a commission on SRHR in the post-2015 world that will begin work in early 2016 with the aim of developing a wide-ranging and evidence-based agenda for key SRHR priorities worldwide over the next 15 years. This Commission will also make the case for adopting policies and High-level advocacy and input to global initiatives for sexual and reproductive health 7 programmes aimedatturning that vision into reality.The coordinator of the Adolescents and at-Risk Populations team of the Department was invited to be a commissioner. Planned activities • The Department will be actively engaged in the process of developing and reporting on the SRHR-related SDGs indicators. • The Department is actively engaged in the Commission on SRHR established by the Guttmacher Institute and The Lancet journal. A staff member participates as one of the 14 Commissioners, who aim to review the evidence, assess gaps, identify key priorities in SRHR for the future, and issue a concise set of recommendations. The work of the Commission will be carried out during 2016 and finalized in 2017. 2.2.3 Global Financing Facility (GFF) Progress The Global Financing Facility (GFF) in Support of EWEC was launched in July 2015 at the Addis Ababa Conference on Financing for Development, to contribute to smart, scaled-up and sustainable financing for women’s, children’s and adolescents’ health. The GFF isintended to facilitate coordination of the flow of funding among key partners in support of national plans, to assist governments to increase domestic resources for health, and to reduce inefficiencies in spending. The GFF is linked to a specific GFF Trust Fund managed by The World Bank that provides an opportunity for 62 low- and lower-middle-income countries to receive grants for women’s, children’s and adolescents’ health linked to the use of International Development Association (IDA) loans. The Department has been involved in supporting the development of the “Investment Cases” in the Democratic Republic of the Congoand Kenya in order for these countries to access the Trust Fund resources. Research conducted by the Department is already helping countries to prioritize their actions. Planned activities • In 2016, the Department will supportcountries on specific SRH issues based on country requests. 2.3 ICPD Beyond 2014 and Beijing +20 Progress In 2015, the Departmentcontinued its efforts to support the ICPD Beyond 2014 review process1 including (i) providing support to the UNFPA-led review of progress and gaps in implementation of the ICPD Programme of Action at the 20th anniversary and (ii) providing technical input to countries on key areas of sexual and reproductive health (SRH). In follow-up to the production of seven fact sheets in 2014 relating to key areas of SRHR, theDepartment worked on the dissemination of this material at key conferences and forums held in 2015.2 The Department also worked on the dissemination of the position paper based on information available on progress and gaps in implementation of the ICPD Programme of Action (4). The position paper highlighted three cross-cutting themes emerging from ongoing evaluation of the ICPD Programme of Action: to address inequalities, to ensure quality of care, and to enhance accountability. 1 Official website available at: http://icpdbeyond2014.org/ 2 The fact sheets are available at: http://www.who.int/reproductivehealth/icpd/en/ Annual Technical Report 20158 The Department has also been involved in the ICPD Geneva Network of Member States, providing technical support on several issues related to SRHR, including: violence against women; family planning; child, early and forced marriage; adolescent health; and development of the post-2015 sustainable development agenda with a specific focus on the role of SRHR in that agenda.In particular, theDepartment provided regular updates on the process of development of: the Global Strategy for Women’s, Children’s and Adolescents’ Health(1); the draft global plan tostrengthen the role of the health systems to address interpersonal violence, in particular against women and girls, and against children;3 and the three draft Global Health Sector Strategies for HIV, viral hepatitis and sexually transmitted infections 2016–2021.4 In 2014, the Department led WHO’s efforts in preparing a paper examining achievements, unfinished agenda items, and emerging priorities relating to women’s health 20 years after the 1995 Fourth World Conference on Women, in Beijing, and the Beijing Declaration and Platform for Action(5). With participation of all relevant WHO Departments, the paper, entitledWomen and health: 20 years of the Beijing Declaration and Platform for Action(6), was completed in December 2014 and subsequently discussed at the WHO Executive Board in January 2015, where Member States affirmed commitment to women’s health and provided guidance on WHO’s roles and activities. In early 2015, the comments from the WHO Executive Board about the paper were incorporated to develop a new version,which was discussed at the World Health Assembly in May 2015(7). Planned activities • The Department will continue to support the follow-up actions on Beijing+20 by providing technical input on health aspects that form part of the discussion. • The Department will remain actively engaged in the Geneva ICPD Network. • Theglobal plan of action to strengthen the role of the health system within a national multisectoral response to address interpersonal violence, in particular against women and girls, and against children, and the Global Health Sector Strategy for sexually transmitted infections will be finalized in early 2016 and discussions at the World Health Assembly in May 2016 will be followed. 2.4 The H4+ mechanism Progress The UN H4+ mechanism, which combines the efforts of UNFPA, UNICEF, WHO, The World Bank, UNAIDS and UN Women, works with countries to support the implementation of commitments to the UN Secretary-General’s Global Strategy for Women’s, Children’s and Adolescents’ Health and the EWEC movement, to accelerate progress towards achieving MDGs 4 and 5. H4+ efforts focus on provision of joint support to countries in planning and implementing effective reproductive, maternal, newborn and child health (RMNCH) interventions, by strengthening the health systems and improving equity in access to quality services. The Department led WHO’s efforts in monitoring support of the more than 75 H4+ priority countries through the development and implementation of a results-based global survey of progress in these countries. The Department used the H4+survey results to: provide an 3 Available at: http://www.who.int/topics/violence/interpersonal-violence-against-women-children/en/ 4 Available at: http://www.who.int/hiv/strategy2016-2021/en/ High-level advocacy and input to global initiatives for sexual and reproductive health 9 updated overview of H4+ country coordination, functionality and activities; synthesize information on H4+ efforts to accelerate implementation of the Global Strategy; and inform the post-2015 development agenda initiatives by documenting and sharing the H4+ lessons learnt on interagency collaboration and joint implementation. The resulting progress report for 2014, found that the H4+ collaboration had improved harmonization of stakeholder agendas and reduced duplication of efforts, thereby turning potentially competitive organizational relationships into partnerships(8). Additionally, the H4+ mechanism was credited with being effective in generating and maintaining support and funding for RMNCH interventions by facilitating external partner alignment with national RMNCH priorities while also mobilizing increased domestic resources for RMNCH at national and subnational levels. Direct support addressing country-specific RMNCH needs was also a reported beneficial effect of H4+ support. The Department was key in providing some of this concentrated technical support to countries, namely through the organization of WHO feedback on 10 country plans for 2015 activities. Planned activities • In 2016, the Department will support the development of transition plans at the country level in response to post-2015 shifts in the funding landscape,and will also explore the evidence base behind key country-driven innovative programmes, such as integrating services for men and boys into RMNCH services. • The Department, in collaboration with all H4+ partner agencies, will contribute to development of the role for H4+ in support of the new Global Strategy for Women’s, Children’s and Adolescents’ Health. 2.5 Collaboration with the Inter-Parliamentary Union and other parliamentarian networks Progress Together with the Inter-Parliamentary Union (IPU), the Department has established a constructive collaboration with other parliamentarian platforms at regional level, such as the European and Pan African Parliaments, which play a crucial role in defining health-related recommendations within their respective regions. Additionally, the Department engages with thematic platforms, such as the Parliamentarian Forums on Population and Development, which have a focus on reproductive health and rights in their respective regions. The goal of the collaboration between the Department and parliamentarians is to better understand the parliamentary processes that can move the global health agenda forward, and to raise the levels of domestic investment in health. Additionally, this cooperation serves the purpose of providing technical support to parliamentarians in the development and implementation of health-related multilateral agreements, resolutions, declarations and other legislative tools. The Department has also established collaborations with national parliaments in the area of SRHR. Under the leadership of the Department, the relationship between WHO and IPU has evolved over the last couple of years to become a systematic cooperation on a range of areas of work, including policy research, accountability, advocacy and technical support for development of legislation and policies as relates to SRHR, and with a focus on a variety of topics, including violence against women, family planning, maternal and child health, and traditional practices (e.g. child, early and forced marriage) as well as women’s and children’s health more broadly. Annual Technical Report 201510 Within this collaboration, a highlightwas the unanimous adoption of the landmark resolution in 2012, Access to health as a basic right: the role of parliaments in addressing key challenges to securing the health of women and children(9). The resolution highlighted the human rights, political and socioeconomic imperatives according to which parliamentarians can act to support women’s and children’s health. As a recent follow-up to thisIPU resolution, the Department supported IPU in a study toreview progress of the implementation of the resolution,the findings of which were presented at the 132nd IPU General Assembly in Hanoi, Viet Nam, in March 2015. In the last year, theDepartment has also formally engaged withparliamentarians and IPU in the process of developing the new Global Strategy for Women’s, Children’s and Adolescents’ Health(1). Parliamentarians have participated in the formal consultations held in Geneva, Johannesburg and New Delhi, which led to the development of the official IPU commitment to the Global Strategy, submitted on 9 September 2015. IPU committed to ensuring that national parliaments continue to play a central role in improving women’s, children’s and adolescents’ health at national, regional and global levels, as well as improving accountability. IPU and the Department have also collaborated in the area of child, early and forced marriage (CEFM) with a specific focus on the impact of legislation on child marriage as related to health outcomes. Results of a first study on 10 African countries were presented at the Pan African Parliament meeting in November 2013, and this was instrumental in the finalization of a Pan African Parliamentary resolution on gender-based violence. The Department and IPU developed a second study on the impact of legislation on CEFM in 37 Asia-Pacific countries. The findings of the study were presented at the Regional Seminar for Asia-Pacific Parliaments “Ending the cycle of violence against girls in Asia-Pacific”, in Dhaka, 23–25 September 2014 (10)and a publication synthetizing the main findings was published in the Review of Faith and International Affairsin 2015 (11). The final study report was prepared during 2015 and will be published in early 2016. In follow upto this work, the Parliament of Bangladesh has requested WHO and IPU to conduct a study on CEFM legislation and health in the country. The Department has also been actively engaged in the context of the IPU Women Speakers of Parliament to support women’s participation and leadership on political, economic and social issues, as well as to promote women’s health as a priority in national agendas. Recently the Department’s Director represented WHO at the Fourth World Conference of Speakers of Parliament, held in New York, USA,in September 2015. Within the context of collaboration with other parliamentary forums, the Department has worked with the European Parliamentary Forum on the G7/G20 Parliamentary Meeting for Women’s and Children’s Health held in Berlin alongside G7 Germany (the G7 Summit 2015). The Department has provided crucial input to the final statement by G7/G20 parliamentarians to be handedover to the German G7 Sherpa. The Department is also working in collaboration with the Italian and Japanese governments in preparation for the 2016 and 2017 G7 summits to position women’s, children’s and adolescents’ health, including sexual and reproductive health (SRH), on the agenda for both summits. Planned activities • In collaboration with parliamentary platforms, the Department plans to continue research on the impact of legislation onCEFM on SRH. High-level advocacy and input to global initiatives for sexual and reproductive health 11 • The Department willcontinue to provide support for the development of SRH- related legislation upon parliaments’ request. • The Department will support IPU in its engagement within the Global Strategy operationalization framework and the accountability mechanisms. • In collaboration with IPU, the Department will develop an online database on CEFM marriage legislation. • The Department plans to collaborate with G7 countries, both at government and parliament level, in preparation for the 2016 and 2017 G7 Summits on issues relating toSRH. 2.6 The Global Fund to Fight AIDS, Tuberculosis and Malaria Progress The Global Fund to Fight AIDS, Tuberculosis and Malaria (the Global Fund) mobilizes, manages and disburses substantial resources for national HIV/AIDS, tuberculosis and malaria programmes. Although much progress has been made, the burden of these diseases is still substantial and disproportionately affects women, adolescent girls, newborns and children, especially in sub-Saharan Africa and South Asia. WHO signed an agreement with the Global Fund to provide country-specific technical support to increase the quality of RMNCHelements in the Concept Notes used to apply for Global Fund support. The Departmenthas contributed to providing technical support to countries in developing proposals that include sexual and reproductive health (SRH) aspects. WHO has conducted multiple capacity-building workshops for RMNCH consultants, partners, ministry of health (MOH) focal persons and WHO staff, involving 15 countries in the WHO African Region. Furthermore, Department staff participated in technical meetings to support Ebola-affected countries in the development of recovery and resilience plans with a focus on funding from Gavi, the Global Fund and other partners, in Accra, Ghana, 9–11 June. Department staff also participated in a five-day technical consultation in Owerri, Nigeria, 15–20 June, to develop a protocol for a pilot project to integrate prevention of mother-to-child transmission (PMTCT) and reproductive, maternal, newborn, child and adolescent health(RMNCAH) as recommended by the Governmental Advisory Committee, and to obtain feedback from Nigerian stakeholders, including participants from nongovernmental organizations (NGOs), government and implementation partners from state, local and federal levels. The technical consultation in Nigeria resulted in a research protocol to conduct a study to assess the viability of integrating an expanded portfolio of services to improve PMTCT of HIV and syphilis within antenatal care (ANC) settings in selected Nigerian states. Planned activities • The Global Fund has identified 20 countries where the rate of implementation is lagging behind and has created an initiative to review the bottlenecks to implementation in these countries, together with a number of partners at the global level.The Department will continue to provide support on SRH aspects of proposals in these countries. 2.7 Family Planning 2020 (FP2020) The Family Planning 2020 (FP2020) partnershipaims to support the rights of an additional 120 million women and girls in the world’s poorest countries to use contraceptive information, services and supplies, without coercion or discrimination, by 2020 in response to high levels Annual Technical Report 201512 of unmet family planning needs, which was the focus of a global summit in London in 2012 initiated by the Government of the United Kingdom of Great Britain and Northern Ireland (United Kingdom) and the Bill & Melinda Gates Foundation. The Department has been a key partner in implementing the objectives of the Summit. Progress In the three years since the London Summit, FP2020 has made remarkable progress, including additional commitments from countries, increased disbursements from donors, and progress across multiple sectors. According to the latest progress report launched on 3 November 2014(12), across the 69 FP2020 focus countries, in 2013, 8.4 million more women and girls were using modern contraception, more than 30 of those countries have made commitments to the FP2020 initiatives, and a total of US$ 1.3 billion has been provided by donor governments. The governing body of the FP2020 partnership is the Reference Group, which sets the overall strategic direction and drives coordination among the partnership’s stakeholders. The Department, has been on board since the inception of the initiative and has contributed actively with the Department Director beinga member of the Reference Group, representing WHO. The Department has also provided technical support to the FP2020 Rights and Empowerment Working Group to ensure that the FP2020 work on contraception and human rights is in line with the guidelines and framework recently developed by WHO, as well as providing technical support in the area of country engagement. Recently FP2020 has gone through a process of strategic review and reform of its structure to accelerate progress over the remaining five years of the partnership. This has led to a stronger role for the FP2020 Secretariat and the Reference Group, as well as the dissolution of theworking groups onRights and Empowerment, Market Dynamics and Country Engagement. The Performance Monitoring and Evidence (PME) Working Group will continue, and the work will be refined to ensure alignment with the new FP2020 priorities. Planned activities • The Department will keep contributing to the FP2020 initiatives on behalf of WHO as a member of both the Reference Group and the PME working group. • The Department will support FP2020 in engaging withparliamentarians and parliamentary forums on issues related to contraception and family planning. 2.8 References 1. Global Strategy for Women’s, Children’s and Adolescents’ Health (http://www. who.int/life-course/partners/global-strategy/globalstrategyreport2016-2030- lowres.pdf, accessed 12 January 2016). 2. Temmerman M, Khosla R, Bhutta Z, Bustreo F (editors). Towards a new global strategy for women’s, children’s and adolescents’ health. BMJ. 2015;351:Suppl1 (http://static.www.bmj.com/sites/default/files/attachments/resources/2015/09/ who_supplement.pdf, accessed 15 January 2016). 3. Transforming our world: the 2030 agenda for sustainable development. United Nations; 2015 (https://sustainabledevelopment.un.org/post2015/ transformingourworld/publication, accessed 25 January 2016). High-level advocacy and input to global initiatives for sexual and reproductive health 13 4. Programme of Action adopted at the International Conference on Population and Development, Cairo, 5–13 September 1994, 20th Anniversary Edition. United Nations Population Fund; 2014 (http://www.unfpa.org/sites/default/files/pub-pdf/ programme_of_action_Web%20ENGLISH.pdf, accessed 25 January 2016). 5. Beijing Declaration and Platform for Action, The Fourth World Conference on Women. Adopted at the 16th plenary meeting, on 15 September 1995. United Nations; 1995 (http://www.un.org/womenwatch/daw/beijing/pdf/BDPfA%20E. pdf, accessed 25 January 2016). 6. Women and health: 20 years of the Beijing Declaration and Platform for Action. Report by the Secretariat. World Health Organization; 2014 (EB136/18; http://apps. who.int/gb/ebwha/pdf_files/EB136/B136_18-en.pdf, accessed 25 January 2015). 7. Women and health: 20 years of the Beijing Declaration and Platform for Action. Geneva: World Health Organization; 2015 (A68/16; http://apps.who.int/gb/ ebwha/pdf_files/WHA68/A68_16-en.pdf, accessed 22 January 2016). 8. H4+ partnership: joint support to improve women’s and children’s health: progress report – 2014. Geneva: WHO, UNICEF, UNFPA, UNAIDS, UN Women, The World Bank; 2015 (http://apps.who.int/iris/bitstream/10665/189285/1/9789241508889_eng. pdf,accessed 25 January 2016). 9. Access to health as a basic right: the role of parliaments in addressing key challenges to securing the health of women and children.Resolution adopted unanimously by the 126th Inter-Parliamentary Union (IPU) Assembly. Kampala: Inter-Parliamentary Union (IPU); 2012 (http://www.ipu.org/conf-e/126/res-3. htm, accessed 25 January 2016). 10. Conclusions of the regional parliamentary seminar on ending the cycle of violence against girls in Asia-Pacific, Dhaka, 23–25 September 2014. Dhaka: Inter-Parliamentary Union and the Parliament of Bangladesh; 2014 (http://www.ipu.org/splz-e/dhaka14/ conclusions.pdf, accessed 25 January 2016). 11. Scolaro E, Blagojevic A, Filion B, Chandra-Mouli V, Say L, Svanemyr J, Temmerman M. Child marriage legislation in the Asia-Pacific Region. Rev Faith Int Affairs. 2015;13(3):23– 31. doi:10.1080/15570274.2015.1075759. 12. FP2020:Commitment to action 2014–2015. FP2020; 2015 (http://progress. familyplanning2020.org/, accessed 25 January 2016). Annual Technical Report 201514 Thematic areas 15 3. Thematic areas 3.1 Family planning and contraception 3.1.1 Introduction Unintended pregnancy, resulting from unmet need for family planning/contraception, is a problem that threatens the lives and well-being of women and girls and their families globally. Populations most impacted are sexually active adolescents, individuals with low socioeconomic status, those living in rural communities, and those coping with conflicts and disasters. Latest estimates indicate that 225 million women in developing countries have an unmet need for modern contraceptive methods (1). The need is greatest within populations where risks of maternal mortality are highest. The mission of the Human Reproduction team in the area of family planning is to reduce the unmet need for family planning and contraception and thus to prevent unintended pregnancy. To achieve this mission, the Departmentis implementing a collaborative, science-driven approach. This section reports on how, in 2015, this approach has translated into concrete and coordinated activities towards strengthening and improving equitable access to quality family planning services at scale and towards maintaining family planning as a global development priority. Major achievements • In 2015, the Department published 25 papers on family planning and contraception. • WHO publishedits eagerly anticipated update of the Medical eligibility criteria for contraceptive use (MEC) guidance and its accompanying job aid for providers of family planning services, the MEC Wheel on 1 June 2015. Through a rigorous review of the latest science addressing contraceptive safety, 14 topics (encompassing more than 575 recommendations) were reviewed as part of the revision process to develop the fifth edition of the MEC. • The Compendium of WHO recommendations for postpartum family planning guidance uses a new user-friendly digital platform to enable easy access to its recommendations. It is aimed at health-care providers who counsel postpartum women on contraceptive options; it helps these providers to quickly and easily access WHO recommendations on what contraceptive options are available for these clients. This tool was completed in December 2015. • The Department provided technical support to 10 countries in the WHO African Region to develop postpartum family planning. 3.1.2 Research and development 184.108.40.206 UPTAKE Project – a health sector and community-based participatory approach in a human rights framework to increase met needs for contraception The UPTAKE Project is a multicountry complex-designed intervention being implemented in Kenya, South Africa and Zambia to increase the participation of the community and health-care providers in the provision of family planning and contraceptives. The Project uses a “Theory of Change” framework to define the pathway to the desired overall Annual Technical Report 201516 outcome, which is to address the unmet need for family planning and contraceptive services within a human rights framework. Progress • The 18-month formative phase was approved by the Research Project Review Panel (RP2) on 28 March 2015 and by WHO’s Ethics Review Committee (WHO-ERC) on 21 May 2015. All local institutional review board (IRB) approvals have also been obtained. The site-initiation meetings were conducted from 21 July to 2 August 2015 at all three sites. • Manuscripts of scoping reviews on approaches to community and health-care provider participation and on definitions of “quality of care” from health-care provider and community perspectives have been completed and were submitted for review in December 2015. • For the formative phase, qualitative research training was conducted in Lusaka for the social scientists and the qualitative research teams from the three countries from 19–21 August 2015. Focus group discussions (FGDs) and in-depth interviews (IDIs) were initiated in September 2015; 14 FGDs and 10 IDIs have been conducted in each country. Legal and policy mapping was initiated in August 2015 and is completed. Mapping of facilities and services began in September 2015, and the findings are being written up. • An investigators’ update meeting took place by WebEx on 10 November 2015 to discuss preliminary results of the formative phase activities, and to plan the next steps, including initiating the development of the approach for engaging the community and health-care providers and for defining the eligibility and matching criteria for the intervention sites. Planned activities • By March 2016, we plan to complete the formative phase activities, disseminate the results and start developing the protocol for the implementation phase. A Working Group meeting is planned for March 2016 to discuss the results of the formative phase and develop the protocol for the implementation phase. • We plan to obtain approvals for the implementation phase protocol from the RP2, WHO-ERC and local IRBs by June 2016. If approved, the implementation phase is expected to begin in August 2016. 220.127.116.11 Reviewing and generating evidence on financing mechanisms for sexual and reproductive health services and commodities including family planning In recent years, various family planning financing schemes have been developed and implemented to assist the poor and vulnerable, including voucher programmes, community- based insurance and others. The evidence base supporting the implementation of these mechanisms, relating specifically to family planning/contraception, is very limited, and where evidence exists it is often of low quality. The present initiative led by the Department aims to strengthen the evidence base on financing mechanisms for family planning/contraception, and thus to provide governments, funding agencies and other donors with evidence-based guidance upon which future programmes and projects can be based. The Department will undertake systematic reviews of the existing evidence with the specific objectives of (i) identifying those areas in which the evidence base for financing of contraception is strong, Thematic areas 17 (ii) identifying the current gaps in knowledge and potential research topics in health- care financing in contraception, and (iii) serving as a basis for initiating dialogue on joint investment in research to fill the gaps identified by the systematic review process. Progress Research teams are conducting systematic reviews of five financing mechanisms for family planning, namely: (a) voucher schemes, (b) performance-based financing, (c) conditional cash transfers, (d) community financing and community-based health insurance and (e) out-of-pocket payments and user fees. The second researchers meeting was held in June 2015 in Geneva, to present and peer review the draft findings, reflect upon and discuss their implications, identify evidence gaps and, most importantly, devise new and innovative research approaches to addressing the gaps. The reviews were finalized in November and disseminated at a large meeting of bilateral, multilateral and nongovernmental donors in the family planning community, in December 2015. The aim of this meeting was to present the results, identify gaps in the research, propose a research agenda to funders and ultimately to begin implementation of the findings. Planned activities • In 2016, the systematic reviews and consolidated findings will be published in a special issue of a leading peer-reviewed journal. 18.104.22.168 Demand-side financing project (voucher programme) for increasing demand and utilization of contraception Lack of access to affordable contraceptive services and commodities is contributing to unmet needs for family planning in many developing countries. Evidence on the best mechanisms to provide these services and commodities affordably for the poor and underserved are limited. Demand-side financing approaches have been implemented to increase access to and uptake of quality family planning services, improve maternal and child health outcomes and achieve national development goals in low-income countries. Progress Two quasi-interventional studies testing two different demand-side financing approaches with voucher schemes (multipurpose versus single vouchers) in Pakistan’s Punjab province were completed, in collaboration with Population Services International (PSI) and Marie Stopes International (MSI). Final reports on the end-line survey findings are currently being prepared. A series of dissemination meetings with the Ministry of Health, the Packard Foundation (donor) and other donors were conducted in 2015 in Pakistan. Planned activities • A series of peer-reviewed papers on the end-line evaluation will be submitted in early 2016 (2–4). 22.214.171.124 Operations research on postpartum family planning in the Democratic Republic of the Congo and Burkina Faso This operations research RCT aims to identify and test the effectiveness of a package of PPFP interventions that reinforce existing pre- and postnatal services. The package of interventions (as conceived in the formative phase) will be delivered at primary health care centres. To assess impact, use of family planning methods immediately Annual Technical Report 201518 postpartum, six days, six weeks, 5–6 months and 8–9 months after delivery will be compared with the usual PPFP services provided at control health centres. Progress The PPFP protocol, guides and tools were approved by RP2 in May 2015 and by WHO- ERC in August 2015 (with conditional approval in July 2015). The pre-formative phase, including identifying and mapping health centres and a review of relevant documents in each country, was completed in July 2015. Three sites were identified in each country for use in the formative phase and the remainder of the sites will be randomly selected as control or experimental sites for the intervention phase. A training workshop on the use of the counselling guide and focus group discussion tools was held in Ouagadougou on 29–31 July 2015 with the principal investigators and data analysts from the two research sites (Burkina Faso and the Democratic Republic of the Congo). Burkina Faso then started the formative phase in August followed by the Democratic Republic of the Congo in October. Formative data collection, for identifying barriers and catalysts as well as for feedback on the counselling tool, was completed in November 2015. On 14–18 December 2015, WHO headquarters organized a workshop for the two country teams and other stakeholders to discuss the final results of the formative phase and the finalization of the PPFP package to be ready for the intervention phase. Planned activities • Based on the results from the formative phase, the PPFP package will be amended for the intervention phase that will start in the first quarter of 2016. The protocol and instruments will be resubmitted to WHO-ERC in early January 2016. 126.96.36.199 Preclinical development of simple and inexpensive depot injectable formulations for combination contraception and HIV prevention The Department has undertaken to develop and test the preclinical feasibility of injectable-type multipurpose prevention technology (MPT) products, including investigations of drug type, drug loading, drug–drug interactions, drug stability and animal model pharmacokinetics, to ascertain the practicalities and constraints of combining two active ingredients within a single injectable delivery system. Progress An RP2 proposal has been approved and initiated in collaboration with Queen’s University Belfast, Northern Ireland, United Kingdom in 2015. Two different injectable formulation strategies will be investigated, the first based on a reformulation of the injectable contraceptive Depo-Provera®, and the second on in situ forming implants. Both strategies will make use of medroxyprogesterone acetate (MPA) as a hormonal contraceptive and one or more of the antiretroviral (ARV) drugs MC1220, rilpivirine (RPV) and cabotegravir (GSK744). Preliminary characterization studies were conducted to evaluate the physico-chemical properties of MPA and the ARV drugs. The studies performed to date demonstrate that MPA, MC1220 and RPV are suitable candidates for the development of MPT injectable formulation products if MC1220 polymorphism is controlled. The characterization studies of the commercial contraceptive Depo-Provera® represent a good basis for further development of depot suspension combinative drug products associating the contraceptive MPA with an ARV candidate. Thematic areas 19 Planned activities • More work will be done to pursue the development of these MPT injectable formulations as depot suspensions and in situ forming implants. 188.8.131.52 Study of the factors affecting access to emergency contraception using levonorgestrel 1.5 mg in Malawi Emergency contraception (EC), as part of a wide range of options, especially for cases of unprotected sex, including cases of sexual assault, or perceived contraceptive failure, has the potential to significantly reduce the incidence of unintended pregnancy and the consequent need for abortion. Progress Results of the study show that essentially all facility-level respondents had heard of EC compared to 78.9% of police officers at victim support units (VSUs), where victims of sexual assault are taken care of. Progestin ECs (especially levonorgestrel) are the most widely available. The most common indication for EC was unprotected sex, burst condom. EC stock-outs in the preceding 12 months were only experienced in 12% of the service-delivery points surveyed. Respondents identified cultural and religious beliefs along with misconceptions related to the view of ECs as “abortion pills” as the main barriers to utilization. Despite wide and consistent availability of ECs, utilization remains low. Police officers working at VSUs are particularly lacking in knowledge on EC. There is a need to address cultural and religious beliefs and common misconceptions within a comprehensive advocacy programme to promote EC utilization. Planned activities • The full study report will be completed for publication in 2016. • More discussions on the roles of the officers at VSUs will be held, with a view to planning more in-depth training. 184.108.40.206 ECHO (the Evidence for Contraceptive options and HIV Outcomes) Trial ECHO is a multicentre, open-label, randomized clinical trial comparing HIV incidence and contraceptive benefits in women using depot medroxyprogesterone acetate (DMPA), levonorgestrel (LNG) implants and copper-bearing intrauterine devices (Cu-IUDs) for contraception. The ECHO Trial will provide the most definitive information concerning the comparative risk of HIV acquisition and other risks and benefits resulting from the use of DMPA or LNG implants, with Cu-IUDs as the control group. The ECHO Trial will be conducted at 12 clinics in southern and eastern Africa. To implement this study, the Department set up the ECHO Consortium, comprising major organizations; it will be jointly led by FHI 360 and WHO. Progress The protocol has been approved by RP2 and the WHO-ERC. Funding has been provided for the East London site in South Africa, which is supported by WHO. The Department participates and provides input during regular management committee and all-site conference calls. On 8–10 December 2015, the Department hosted an annual meeting of researchers, policy-makers, implementers, civil society and other stakeholders engaged in research, Annual Technical Report 201520 programmes or policy on hormonal contraception and HIV. The meeting identified research, policy and programme gaps in the field. Planned activities • Enrolment of study participants started in December 2015 as most of the site activation visits had been done and the study products had been procured. Study enrolment will continue in 2016. • The next meeting is scheduled for November 2016. 220.127.116.11 Effect of combined contraceptive pills on exclusive breastfeeding and infant weight gain; a double-blind randomized clinical trial of combined and progestogen-only pills with an observational control group of IUD users The uncertainty and controversy about the safety of combined oral contraceptives (COCs) during breastfeeding can only be resolved through attaining high-quality data from a double-blinded RCT on the effect of COCs on breastfeeding, adding an observational control group of women using IUDs during breastfeeding. This will be an international, multicentre trial in which healthy, exclusively breastfeeding women with singleton healthy infants born after full-term pregnancies will be enrolled after consenting to be randomized either to COCs (30 µg ethinylestradiol, 150 µg LNG) or to progestogen-only pills (POPs; 30 µg LNG), starting the pills after six completed weeks postpartum. Additionally, exclusively breastfeeding women choosing Cu-IUD for contraception will, after consent, be enrolled and frequency-matched by parity (nulliparity, parity 1+) and age (5-year age bands) to every second woman randomized to COCs or POPs. Progress The project protocol is under review by RP2. Planned activities • An expert working group meeting will be held in January 2016, followed by initiation meetings and local IRB approvals in four countries. 18.104.22.168 Multicentre randomized clinical trial of two implantable contraceptives for women: two-rod levonorgestrel implant (Jadelle) and one-rod etonorgestrel implant (Implanon) Contraceptive implants are increasingly popular worldwide. Implanon® is a single-rod, implant that contains the progestin etonogestrel, providing contraceptive protection for up to three years. Jadelle® has two LNG rods and provides protection for up to five years. The safety and efficacy of single-rod versus two-rod contraceptive implants were investigated in a multicentre clinical trial. The study was conducted in seven countries: Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. In total, 2963 women have been randomized to one of the two implants, while 971 women using the Cu-IUD (TCu 380A) were enrolled as an age-matched cohort. An article presenting the baseline characteristics of the study groups was published in Contraception in 2013 (5). Progress Results of the study indicating that both contraceptive implants are safe and highly effective for up to three years of use, and that their effects are rapidly reversible upon removal, have been published and are available online in the journal, Human Reproduction(6). Abstracts Thematic areas 21 reporting on five years of follow-up assessments were presented at the International Federation of Gynecology and Obstetrics (FIGO) World Congress in Vancouver, 2015, and at the Reproductive Health Supplies Congress in Oslo, 2015. Planned activities • A manuscript reporting on the five-year follow-up of clients in the implant study will be submitted to a peer-reviewed journal in the first quarter of 2016. 22.214.171.124 A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of the peri-coital oral contraception using levonorgestrel 1.5 mg Levonoregestrel (LNG) 1.5 mg is an effective emergency contraceptive that can be taken following unprotected intercourse. Some users take it repeatedly, as their means of regular contraception. This has raised the question of whether the use of LNG 1.5 mg on each day of coitus by women who have relatively infrequent sex may be an efficacious, safe and acceptable contraceptive method. A study on this topic was conducted in four countries: Brazil, Hungary, Singapore and Thailand. There were 321 women who were included in the evaluable population, with 141.9 woman-years of observation and with a rate of 7.1 (95% confidence interval [CI]: 3.8–13.1) pregnancies per 100 woman-years of typical use, and 7.5 (4.0–13.9) pregnancies per 100 woman-years of sole use. In the primary evaluable population (women under 35 years old), the rate was 10.3 (5.4–19.9) pregnancies per 100 woman- years of typical use, and 11.0 (5.7–13.1) pregnancies per 100 woman-years of sole use. There were three reported severe adverse events and 102 other mild adverse events, with high recovery rate. The most common adverse events were headache, nausea and abdominal and pelvic pain. Vaginal bleeding patterns showed a slight decrease in volume of bleeding and the number of bleeding-free days increased over time. The method was considered acceptable, as over 90% of participants would choose to use it in the future or would recommend it to others. Progress This paper was presented at the FIGO World Congress in Vancouver (October 2015). The paper has also been accepted for publication in Human Reproduction in early 2016 (7). Planned activities • The paper will be presented at the International Conference on Family Planning (ICFP) in Bali, Indonesia, in January 2016. • The next steps for further research on peri-coital contraception are being discussed with partners and donor agencies. • The further research ideas will be presented at the European Society of Contraception and Reproductive Health Congress in Basel, Switzerland, in May 2016. 3.1.3 Norms, standards and tools 126.96.36.199 Medical eligibility criteria for contraceptive use, fifth edition Over the past 40 years, there have been significant advances in the development of new contraceptive technologies, including changes in formulations and dosing, schedules for administration and novel delivery systems. However, current policies and health-care practices in some countries are based on scientific studies of Annual Technical Report 201522 contraceptive products that are no longer in wide use, on long-standing theoretical concerns that have never been substantiated or on the personal preference or bias of service providers. These outdated policies or practices often result in limitations to both the quality of and the access to family planning services for clients. The goal of the document, Medical eligibility criteria for contraceptive use, is to improve access to and quality of family planning services, by providing policy-makers, decision-makers and the scientific community with recommendations that can be used for developing or revising national guidelines on medical eligibility criteria used in the provision of all hormonal contraceptives, IUDs, barrier methods, fertility awareness-based (FAB) methods, coitus interruptus, lactational amenorrhoea method (LAM), male and female sterilization, and emergency contraception. Progress On 1 June 2015, WHO issued its eagerly anticipated update of the Medical eligibility criteria for contraceptive use (MEC) guidance (8) and its accompanying job aid for health-care providers of family planning services, the MEC Wheel (9). Through a rigorous review of the latest science addressing contraceptive safety, 14 topics (encompassing more than 575 recommendations) were reviewed as part of the process to develop the fifth edition of the MEC. Key highlights of the revision are as follows: • inclusion of four additional methods in the guidance; • relaxed restrictions on several contraceptive methods for breastfeeding women in the postpartum period; • more contraceptive options for women taking antiretroviral medications; • reiteration of eligibility for all contraceptive methods for adolescents; and • clearer guidance for women at high risk of sexually transmitted infections (STIs) and women at high risk of HIV infection. To ensure that this updated guidance reaches front-line health-care providers as quickly as possible, a 2015 edition of the MEC Wheel was prepared (9). The 2015 MEC Wheel features the latest recommendations, additional contraceptive methods, a layout that is more in line with clinical decision-making and more guidance for breastfeeding and postpartum women. Following the release of the updated guidance, key recommendations within the MEC fifth edition were presented during numerous international meetings, including the International Council of Nurses (June 2015), the Asia-Pacific Regional Meeting of the International Confederation of Midwives (July 2015), and the FIGO World Congress (October 2015). Further, the guidance was presented during principle regional events, notably in the WHO Region of the Americas and the WHO African Region. Lastly, a half-day session, which included a panel and small-group discussions, was organized during the Implementing Best Practices (IBP) semi-annual meeting of partners to maximize the implementation of the latest MEC recommendations (June 2015). Publication of the scientific foundation of WHO’s recommendations on contraceptive safety continues to be a high priority. As such, since August 2014 more than eight systematic reviews have been published in open-access format in the journal Contraception (10–17). Moreover, a paper identifying the principle remaining research gaps has been published to help identify priorities and stimulate further research (18). In addition, a commentary summarizing the development of the MEC over the past 20 years and future directions was published in a special issue of Current Clinical Opinion for Obstetrics and Gynecology (19). Thematic areas 23 Translations of the MEC guideline and the MEC Wheel into French and Spanish were initiated. The Government of Brazil will support and undertake the Portuguese translation of the two resources. Planned activities • During 2016, systematic reviews summarizing the body of evidence addressing (i) hormonal contraception and HIV acquisition risk and (ii) hormonal contraception and drug interactions with ARV medications will be updated and published in peer-reviewed journals. These reviews will be sent through WHO’s Continuous Identification of Research Evidence (CIRE) system for assessment by experts on contraceptive safety. • French and Spanish translations of the 2015 MEC guidance and MEC Wheel will be finalized, published and widely distributed. • Anticipated conferences for further dissemination of the MEC and MEC Wheel include the 2016 European Society for Contraception and the 2016 Societé de Contraception Francophone meetings. • Responding to WHO’s commitment to the Family Planning 2020 (FP2020) initiative, the Department will provide targeted technical assistance to Member States to implement the latest MEC recommendations. 188.8.131.52 Selected practice recommendations for contraceptive use, third edition Since 2001, WHO has issued the guideline, Selected practice recommendations for contraceptive use (SPR), with the goal of providing guidance to policy-makers, programme managers and the scientific community in the form of a set of evidence-based recommendations on how to use contraceptive methods safely and effectively once they are deemed to be medically appropriate. The document aims to provide guidance to national family planning/ reproductive health programmes in the preparation of national guidelines for contraceptive service delivery. Moreover, the SPR addresses ongoing controversies and inconsistencies regarding how to maximize the effectiveness of contraceptive methods and how to manage their side-effects or other problems during use (20). Progress A draft of the third edition of the SPR guideline was prepared and sent for external review in December 2015. The third edition of the SPR includes service delivery recommendations for five additional contraceptive methods (the combined contraceptive patch, the combined contraceptive vaginal ring, subcutaneously administered DMPA, ulipristal acetate for emergency contraception and Sino-implant (II)) and new guidance on how to initiate regular contraception after taking emergency contraception. Planned activities • Following external peer review, the draft third edition of the SPR will be submitted to WHO’s Guidelines Review Committee in January 2016. It is envisioned that the finalized guidance will be published in early 2016. • Efforts to publicize the release of the new guidance through the Department’s partners and networks, including social media, will be employed. Additionally, opportunities for dissemination of the updated guidance during upcoming professional conferences will be sought. Annual Technical Report 201524 • Translation of the guidance into French and Spanish will be undertaken as soon as possible. 184.108.40.206 Compendium of WHO recommendations for postpartum family planning Progress In response to the growing global recognition of the very high unmet need for family planning among women during the immediate and extended postpartum period, and confusion among providers and policy-makers as to how to interpret and apply the complex recommendations, WHO has developed a new user-friendly digital platform to enable easy access to its recommendations. Aimed at health-care providers who counsel postpartum womenon contraceptive options, the Compendium of WHO recommendations for postpartum family planning helps these providers quickly and easily access WHO recommendations on what contraceptive options are available for postpartum women (21). Planned activities • Launch of the Compendium will take place on 26 January 2016 at the ICFP, in Bali, Indonesia. • During 2016, the Compendium will be demonstrated and presented during numerous professional meetings (e.g. the 11th Biennial Conference of the Global Network of WHO Collaborating Centres for Nursing and Midwifery, July 2016), as well as regional technical meetings involving WHO regional offices and IBP partners. A commentary that announces the availability of the Compendium and summarizes its key features will be published in a peer-reviewed journal to ensure the professional community is aware of the new resource. Moreover, WHO will respond to requests for technical assistance from Member States to implement the digital resource. 220.127.116.11 Family planning global handbook WHO’s publication, Family planning: a global handbook for providers, offers evidence- based information for contraceptive service delivery for front-line health-care providers offering services to clients (22). This resource incorporates recommendations from the Medical eligibility criteria for contraceptive use (MEC) and the Selected practice recommendations for contraceptive use (SPR) guidelines (8, 20). It also includes many other useful pieces of information that health-care providers need to know when counselling clients on contraceptive safety and efficacy, as well as instructing clients on how to use methods and address problems and/or concerns they may have. Progress Updating of Family planning: a global handbook for providers was initiated in November 2015. While the bulk of the revised edition will focus on ensuring that the recommendations in the fifth edition of the MEC and the soon-to-be released third edition of the SPR are incorporated into the manual, additional WHO guidance on other relevant sexual and reproductive health topics will also be addressed in the revision. Planned activities • The 2016 edition of Family planning: a global handbook for providers will be finalized in early 2016 and sent for peer review prior to publication of this popular health-care provider reference, which is anticipated for mid-2016. Through collaboration with the Johns Hopkins Center for Communication Programs, translations of the handbook into numerous languages will be initiated. Thematic areas 25 18.104.22.168 Medical eligibility criteria for contraceptive use (MEC) and Selected practice recommendations for contraceptive use (SPR) implementation guide Responding to requests from Member States over the years for further clarifications on how programmes can implement recommendations within the MEC and SPR guidelines effectively, the Department will develop a MEC and SPR implementation guide. This document will address issues such as how to differentiate recommendations classified as a MEC category 2 and 3, and how to address issues related to follow-up, exams, tests and other concerns that programmes confront when implementing the guidance in these documents. Progress The Department established an Implementation Guide Working Group to undertake the development of the MEC and SPR implementation guide, which will serve as a resource to accompany these two guidelines. The bulk of the multidisciplinary Working Group’s work will be undertaken during 2016. Planned activities • Through an evidence-informed and consultative process, the Implementation Guide Working Group will advise the Department on the development of the implementation guide during 2016. Two technical stakeholder consultations are envisioned to ensure that the resource is accurate and informed and that it responds to the realities facing national programmes and implementing agencies and partners. • The Department plans to finalize the guide by the end of 2016. 22.214.171.124 Family Planning Training Resource Package The Family Planning Training Resource Package (TRP) is a comprehensive set of instructional materials and curricular components to design, implement and evaluate training. It provides organizations with essential resources for trainers and programme managers, for pre-service and in-service training, for both the public and private sectors (23). The TRP is used by instructors and curriculum developers for high-quality training and customized to meet the needs of specific audiences. Regular updates will incorporate new materials and comply with the latest technical changes in content. Each module includes: session plans and training schedules; facilitator’s guide; presentation slides; interactive group and self-study activities, and case studies; job aids, learning guides, knowledge and skills evaluations; and references. Progress Thirteen modules are in English, with new modules on emergency contraception (for family planning providers and pharmacists) and the Standard Days Method. Many additional key documents have been translated into French, with Spanish translations planned. A workshop was conducted in 2015 during the FIGO World Congress in Vancouver, and in countries (Tanzania, Malawi and the Philippines, etc.). In addition, technical assistance was offered to Timor Leste to revise their training curriculum. Planned activities • A project to assess the impact of using the TRP in countries will be conducted in 2016. • A workshop will be conducted at the ICFP in Bali, Indonesia, in January 2016. Annual Technical Report 201526 • New modules on female sterilization and vasectomy are being developed. • Translations of the remaining key documents into French and Spanish are being pursued. • Country and regional workshops are being planned. 3.1.4. Monitoring and evaluation 126.96.36.199 Human rights and family planning indicators and quality assessment tool for contraceptive programmes This work focuses on strengthening the capacity of health systems to monitor human rights dimensions in contraceptive programmes. The objective of this work is to develop a global approach to support regions and countries in ensuring accountability by strengthening the monitoring and evaluation (M&E) capacity of human rights dimensions in contraceptive programmes. WHO has developed a process for identifying existing quantitative health indicators that can be used in a rights-based analysis to provide a baseline assessment (24). This process has been applied to existing quantitative health indicators, and 12 indicators have been prioritized. A method for systematically analysing these indicators has been developed. Progress Building on this previous work, a new draft report is under preparation, which acknowledges the limitations of only using quantitative indicators to monitor rights, and identifies areas where additional measures are needed (novel quantitative, qualitative or policy indicators). This work will contribute towards development of a tool that can be used globally in contraceptive programmes to monitor human rights dimensions. The tool is being developed as an extension of the Department’s work on contraception and human rights, and will be refined through regional consultations for input and reviews. Key partners and stakeholders have been engaged in the process from inception to ensure ownership in the development of the tool, and its broad adoption globally. An expert group meeting was held in December 2015 with the main purpose of providing input to the work done on tools for M&E. The expert group reviewed and identified technical gaps and priorities, made recommendations on technical and operational methods, and reviewed activities and outputs as necessary. Planned activities • The draft document will be revised, and input and feedback received will be incorporated in January 2016. • The tool will be completed in late 2016. • Pilot testing of the tool in three proposed countries – Kenya, Nigeria and the United Republic of Tanzania – will take place in mid-2016. • Translation of the tool into French from the English version will be undertaken in late 2016. • Results will be reviewed at the second meeting of the expert group in July 2016 followed by implementation/dissemination in the field in late 2016/early 2017. Thematic areas 27 188.8.131.52 Strengthening family planning and contraceptive services using WHO contraception guidelines This work focuses on strengthening the capacity of health systems in assessment of quality of care in contraceptive programmes. The main areas of work on strengthening quality of care in contraceptive programmes at the Department include (i) primary research and research synthesis, (ii) development and dissemination, via efficient mechanisms, of international clinical standards and guidelines based on research evidence and (iii) M&E of the capacity for informed decision-making within family planning programmes at country and regional levels. Progress An expert group meeting was held in October 2015 with the main purpose of providing input to the draft document on quality assessment of contraceptive programmes. The expert group reviewed and identified technical gaps and priorities, made recommendations on technical and operational methods, and reviewed activities and outputs as necessary. The end output – an updated tool for assessing quality from a human rights perspective in contraceptive programmes – will be tool that will facilitate implementation of the principles and recommendations provided in the recently developed WHO guidelines on Ensuring human rights in the provision of contraceptive information and services(25). Planned activities • The draft document will be revised and input received during the October 2015 consultation will be incorporated; the revised document will be available in early 2016. • Translation of the tool into French from the English version will be done in mid-2016. • Pilot testing of the tool in three proposed countries – Kenya, Nigeria and the United Republic of Tanzania – will take place in January–April 2016. • The results will be reviewed at the second meeting of the expert group in June 2016, followed by revision and finalization of the tool in mid-2016 and implementation/dissemination in the field in late 2016. 3.1.5 Disseminations and partnerships The work included under dissemination and partnerships is intended to support utilization of evidence in countries through the systematic introduction of science- driven solutions and a systematic approach to scaling up those solutions. 184.108.40.206 Activities of the Implementing Best Practices (IBP) initiative In 1999, the Department, the United States Agency for International Development (USAID), the UNFPA and nine other agencies created the IBP initiative to work at the global, regional and country levels to foster collaboration, reduce duplication of efforts and harmonize approaches to support the identification, implementation and scaling up of effective technical and managerial practices to improve reproductive health. With the IBP Secretariat based in the Department, the partnership has now grown to 45 organizations, allowing for close collaboration between the Department and the IBP partners. The IBP initiative is finalizing a new strategic plan that will guide the project during the period 2016–2020. An assessment of the 2011–2016 strategy was conducted between Annual Technical Report 201528 June and August 2015 to lay the foundation for the new strategic plan. The objectives of the IBP initiative are reached through a combination of activities, some of which are highlighted below. Progress (i) Supporting countries and regional bodies to document, scale up and share effective reproductive health practices The IBP Secretariat at WHO worked closely with the West African Health Organisation (WAHO) and IBP partners to provide technical and financial support to organize the WAHO Good Practices Forum in Health. The IBP Secretariat also co-facilitated two planning meetings with WAHO (in January and April 2015) to prepare for the Good Practices Forum. The first focused on developing a guide for documenting the implementation of good practices in nine of the WAHO countries and the second helped to prepare for workshops in each of these countries prior to the Forum. Together with USAID, Evidence to Action (E2A) and other partners, the IBP Secretariat organized a pre-forum workshop entitled “Fostering change for scale-up of good practices in the WAHO Region”. More than 100 ministry of health focal points, officials and nongovernmental organization (NGO) partners from across West Africa attended. This workshop was meant as an introduction regarding the need to plan for systematic scale-up of practices. Participants were expected to take the lessons learnt as discussed at the workshop and keep them in mind throughout the Good Practices Forum. The first Economic Community of West Africa States (ECOWAS) Good Practices Forum in Health, held in Ouagadougou, Burkina Faso, 29–31 July 2015, was a great success with more than 300 participants from the 15 ECOWAS countries. The level of enthusiasm and participation was impressive. The June 2015 semi-annual IBP meeting took place in Addis Ababa; it was the first to take place in Africa. Over 220 people attended the meeting, including IBP partners’ colleagues from East Africa, with the goal of deepening their involvement in IBP. (ii) Partnership and knowledge management In June 2015, IBP started to update and reshape the IBP Strategic Framework for 2016– 2020. The new strategy will better reflect changes in the family planning landscape and strengthen the ability and commitment of IBP member organizations to actively engage in the work of the IBP Consortium. A final draft of the new IBP strategy was presented to the IBP Consortium members and steering committee at the semi-annual meeting in Washington, DC, 10–11 December 2015. An opportunity for comments was given at both of these meetings with relevant suggestions being incorporated into the final version. With partners, the IBP Secretariat organized several webinars in 2015 including: An introduction to the high impact practices (HIPs) for family planning; Standards for identifying evidence-based practices in reproductive health; Overview of the fostering change framework; and Learning through implementation: reaching first-time parents and young married women in Burkina Faso. Over the last year, the IBP Knowledge Gateway (KG) has grown steadily with an average of 750 new members per month. After our semi-annual meetings in June and December, new membership peaked. The total membership now stands at over 66 000 and 48 new communities of practice were created in 2015. There are now over 900 communities Thematic areas 29 of practice; 143 were active over the last year and 73 within the last month. The KG averages over 1200 contributions per month, which is on par with the past few years. Planned activities • Five interactive sessions are planned for the ICFP in Bali, Indonesia (January 2016), which will focus on key issues in family planning today, especially scaling up and using partnerships to be successful. In addition, 10 ICFP workshops will focus on IBP tools, approaches and key issues with a view to improving family planning programmes worldwide. • A two-page infographic has been developed to depict IBP’s involvement since the first ICFP in 2009. It also provides additional information on the 2013 ICFP in Addis Ababa. This will be distributed at the ICFP.5 • The Department will follow up with WAHO on the next steps after the 2015 Forum on Good Practices. Activities to develop more widespread capacity to document the implementation of good practices and develop capacity to plan for the scale-up of good practices will be the focus of IBP partner interventions in 2016. • The Department will continue to support partners to use the IBP Knowledge Gateway and conduct webinars on key issues in reproductive health. • The new IBP strategy will be disseminated widely to members at all levels of their organizations. • Due to the great success of the Addis Ababa IBP semi-annual meeting in June 2015, it is envisioned that one of the two 2016 semi-annual meetings will take place in Latin America. • Virtual discussion forums will be organized in French on the MEC and MEC wheel (8, 9), the Compendium of WHO recommendations for postpartum family planning (21), and on task shifting implementation and scale-up issues. 220.127.116.11 Strengthening family planning services in the WHO African Region through increased utilization of WHO tools and guidelines The Department is advocating for and promoting the use of its contraception guidelines, facilitating regional and national adaptations of WHO recommendations, and providing technical assistance to Member States through regional and sub- regional mechanisms. Specifically, in 2015 the Department supported: (a) development of a comprehensive package of resources for countries to implement a coordinated effort for the introduction, adaptation, implementation and scale-up of new contraceptive tools and WHO-endorsed practices; and (b) regional capacity-building to work with countries to document successes, challenges and ways of overcoming challenges during implementation of evidence-based interventions, including those endorsed in WHO guidelines – this improved capacity is intended to provide a basis for improving successful family planning services. 5 The infographic is available at: http://www.ibpinitiative.org/images/ICFP2016IBPPoster.pdf Annual Technical Report 201530 Progress (i) Participation in Chiang Mai meeting on postpartum family planning (PPFP) WHO staff participated in a meeting organized by FP2020 and Jhpiego in June 2015 in Chiang Mai, Thailand, on “Accelerating access to postpartum family planning in sub-Saharan Africa and Asia”. WHO focused on implementation of PPFP programmes in the 10 countries in the WHO African Region that were targeted for the Chiang Mai meeting. In order to ensure WHO’s involvement from the beginning, the Department invited colleagues from the WHO Regional Office for Africa, three staff from the Intercountry Support Teams (ISTs) and national professional officers from the 10 selected WHO country offices to participate in the meeting. (ii) Brazzaville meeting to actively involve WHO’s Regional Office and follow-up to the Chiang Mai meeting The Department and the WHO Regional Office for Africa organized a regional consultation in Brazzaville, Congo, in September 2015, to discuss progress on the 10 countries’ PPFP workplans, which will receive support from the Department. The meeting was also an opportunity to understand the entire project and to have the Regional Office’s full engagement. Next steps were developed to ensure good coordination and communication between WHO headquarters, the WHO Regional Office for Africa and the countries. The need for an explicit plan for monitoring the grant and reporting on implementation, as well as a plan for funding levels for each activity was identified and these plans are being developed. (iii) Product development: implementation package After the IBP Addis Ababa semi-annual meeting in June 2015, a consultation of partners and WHO National Professional Officers (NPOs) was held to discuss the implementation package being put together under the WHO Umbrella project. Participants agreed there was a need for a “how-to” guide to help in the use of the existing tools. In addition, it was felt that an update of the FP advocacy toolkit for inclusion in the package would be very valuable. The update is under way. (iv) Finalizing a guide for documentation with WHO’s Regional Office for Africa and WAHO WHO headquarters and the WHO Regional Office for Africa have undertaken work to update and merge the WAHO documentation tool and the Regional Office’s tool to document best practices. Planning has begun and a consultation is planned for early 2016 to guide the development of the tool. Planned activities • The Department will continue to follow up and support WHO regional and country offices and partners from the 10 country teams working on PPFP action plans (generated at the Chiang Mai meeting). Countries will focus on coordination and M&E of the PPFP action plans as well as ensuring that the updated MEC and related tools are used to strengthen programmes. • A follow-up meeting will be convened by FP2020 and Jhpiego at the ICFP conference in Bali, Indonesia, in January 2016. WHO headquarters invited the same colleagues from WHO country and regional offices to accompany country teams and discuss the current status of the workplans. Thematic areas 31 • The implementation package and the documentation tool will be finalized and tested, followed by training of ISTs and partners in their use. • A subregional consultation will be held on task sharing, with the Ouagadougou Partnership (OP). The OP has nine priority countries that will develop country action plans, which WHO country offices will support along with partners. • Through the IBP Knowledge Gateway, virtual communities of practice will be created for WHO colleagues and partners involved in the WHO Umbrella project to allow continued interactions, sharing of lessons learnt and dissemination of new tools on a regular basis. 18.104.22.168 FIGO workshops on MEC and other WHO family planning guidelines Progress The two one-day workshops covered recent WHO guidelines and dissemination tools on contraception and maternal and perinatal health. The workshops were attended by representatives of national member associations, members of the FIGO Safe Motherhood Committee, FIGO senior executives and staff from the Department and the WHO Department of Maternal, Newborn, Child and Adolescent Health. Planned activities • It was agreed that a coordination mechanism between WHO and health-care professional associations (i.e. FIGO, International Confederation of Midwives [ICM], International Paediatric Association [IPA]) should be developed to streamline the production of evidence-based guidelines. To facilitate this process, a WHO–FIGO working group will be established to develop and follow up concrete proposals. 22.214.171.124 Classification of contraception methods: meeting and decisions There remain inconsistencies in the definition and criteria for classifying contraceptive methods as “modern” contraceptives. The Department and USAID therefore convened a technical consultation in January 2015 to address issues related to classifying contraceptives. Progress The consultation agreed that, as a basic premise, reporting systems need to be consistent in having clear and well defined criteria when classifying contraceptives as “modern” and “traditional”. Methods that are actively included in country programming, including FAB methods – such as the Standard Days Method, the Billings (Cervical Mucus) Method, the Sympto-thermal Method and the Two-Day Method – should be considered as modern methods. Data on their use should be collected and reported separately in countries where these methods are promoted in family planning programmes. In regions where LAM is promoted, taught and used, it should be reported as a modern method. Withdrawal should continue to be classified as a traditional method as it is not included among methods actively promoted in programmes and contributes significantly to overall contraceptive use. Herbs, charms, folk methods and vaginal douching should not be classified as contraceptive methods as they have no scientific basis for being effective in preventing pregnancy and they are not being promoted in any family planning programmes. Further work, especially on training and programming, is needed to define and measure use of emergency contraception to reflect its contribution to reducing unmet need for family planning. Annual Technical Report 201532 It is important that WHO identifies a classification system that is evidence-based and guided by the goal of improving access to a wide range of methods of assured quality that are effective, acceptable and affordable for women and men. Measurement challenges will need to be addressed, but they should not be the driving force to determine which methods are counted as modern and which are not. The ideal contraceptive classification system should be simple, should lead to greater clarity, consistency and parsimony, and should be easy to use and understand by a broad set of stakeholders, including researchers, programme managers, policy-makers, and other potential users. However, any changes should not be overly disruptive to present systems of data reporting or jeopardise the ability to evaluate trends. A paper was prepared based on the technical consultation, including a table of contraceptives and classification systems. Planned activities • The paper from the meeting has been submitted for peer review and publication is expected in 2016. 3.1.6 References 1. Adding it up: investing in sexual and reproductive health. New York (NY): Guttmacher Institute and United Nations Population Fund; 2014 (https://www.guttmacher.org/ pubs/FB-AddingItUp2014.html,accessed 27 January 2016) 2. Azmat SK, Ali M, Ishaque M, Mustafa G, Hameed W, Khan OF et al. Assessing predictors of contraceptive use and demand for family planning services in under-served areas of Punjab province in Pakistan: results of a cross-sectional baseline survey. Reprod Health. 2015;12:25. doi:10.1186/s12978-015-0016-9. 3. Azmat SK, Hameed W, Ali M, Ishaque M, Mustafa G, Khan OF, Abbas G. Comparing effectiveness of two client follow-up approaches in sustaining the use of long acting reversible contraceptives (LARC) among the underserved in rural Punjab, Pakistan: a study protocol and participants profile. Reprod Health. 2015;12:9. doi:10.1186/1742-4755-12-9. 4. Hameed W, Azmat SK, Ali M, Hussain W, Mustafa G, Ishaque M et al. Determinants of method switching among social franchise clients who discontinued the use of intrauterine contraceptive device. Int J Reprod Med. 2015;ID 941708. doi:10.1155/2015/941708. 5. Meirik O, Brache V, Orawan K, Habib NA, Schmidt J, Ortayli N et al; WHO Study Group on Contraceptive Implants for Women. A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data. Contraception. 2013;87(1):113–20. doi:10.1016/j.contraception.2012.08.044. 6. Bahamondes L, Brache V, Meirik O, Ali M, Habib N, Landoulsi S; WHO Study Group on Contraceptive Implants for Women. A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls. Hum Reprod. 2015;30(11):2527–38. doi:10.1093/humrep/dev221. 7. Festin MPR, Bahamondes L, Nguyen TMH, Habib N, Thamkhantho M, Singh K et al. A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1.5 mg. Hum Reprod. 2016.doi:10.1093/humrep/dev341. Thematic areas 33 8. Medical eligibility criteria for contraceptive use, fifth edition. Geneva: World Health Organization; 2015 (http://www.who.int/reproductivehealth/ publications/family_planning/MEC-5/en/, accessed on 18 January 2016). 9. WHO medical eligibility criteria wheel for contraceptive use – 2015 update. Geneva: World Health Organization; 2015 (http://apps.who.int/iris/ bitstream/10665/173585/1/9789241549257_eng.pdf, accessed 26 January 2016). 10. Carr SL, Gaffield ME, Dragoman MV, Philips S. Safety of the progesterone-releasing vaginal ring (PVR) among lactating women: a systematic review. Contraception. 2015;pii:S0010-7824(15)00136-5. doi:10.1016/j.contraception.2015.04.001. 11. Phillips SJ, Tepper NK, Kapp N, Nanda K, Temmerman M, Curtis KM. Progestogen-only contraceptive use among breastfeeding women: a systematic review. Contraception. 2015;pii:S0010-7824(15)00585-5. doi:10.1016/j.contraception.2015.09.010. 12. Tepper NK, Phillips SJ, Kapp N, Gaffield ME, Curtis KM. Combined hormonal contraceptive use among breastfeeding women: an updated systematic review. Contraception. 2015;pii:S0010-7824(15)00218-8. doi:10.1016/j. contraception.2015.04.001. 13. Dragoman M, Curtis KM, Gaffield ME. Combined hormonal contraceptive use among women with known dyslipidaemias: a systematic review of critical safety outcomes. Contraception. 2015 (in press). doi:10.1016/j. contraception.2015.08.002. 14. Phillips SJ, Polis CB, Curtis KM. The safety of hormonal contraceptives for women living with HIV and their sexual partners. Contraception. 2016;93(1):11–6. doi:10.1016/j.contraception.2015. 15. Jatlaoui TC, Riley H, Curtis KM. Safety data for levonorgestrel, ulipristal acetate and Yuzpe regimens for emergency contraception. Contraception. 2016;93(2):93–112. doi:10.1016/j.contraception.2015. 16. Tepper NK, Marchbanks PA, Curtis KM. Superficial venous disease and combined hormonal contraceptives: a systematic review. Contraception. 2015;pii:S0010-7824(15)00128-6. doi:10.1016/j.contraception.2015.03.010. 17. Polis CB, Phillips SJ, Curtis KM, Westreich DJ, Steyn PS, Raymond E et al. Hormonal contraceptive methods and risk of HIV acquisition in women: a systematic review of epidemiological evidence. Contraception. 2014;90(4):360–90. doi:10.1016/j. contraception.2014.07.009. 18. Dragoman M, Jatlaoui T, Nanda K, Curtis KM, Gaffield ME. Research gaps identified during the 2014 update of the WHO medical eligibility criteria for contraceptive use and selected practice recommendations for contraceptive use. Contraception. 2015;pii:S0010-7824(15)30068-8. doi:10.1016/j. contraception.2015.12.009. 19. Altshuler AL, Gaffield ME, Kiarie JN. The WHO’s medical eligibility criteria for contraceptive use: 20 years of global guidance. Curr Opin Obstet Gynecol. 2015;27(6):451–9. doi:10.1097/GCO.0000000000000212. 20. Selected practice recommendations for contraceptive use, second edition. Geneva: World Health Organization; 2004 (http://apps.who.int/iris/ bitstream/10665/43097/1/9241562846.pdf, accessed 27 January 2016). Annual Technical Report 201534 21. Compendium of WHO recommendations for postpartum family planning. Geneva: World Health Organization; 2015 (http://srhr.org/postpartumfp/, accessed 26 January 2016). 22. Family planning: a global handbook for providers (website). Geneva: World Health Organization; 2015 (https://www.fphandbook.org/, accessed 26 January 2016). 23. The training resource package for family planning [website]. United States Agency for International Development, World Health Organization, United Nations Population Fund; 2016 (www.fptraining.org, accessed 27 January 2016). 24. Ensuring human rights within contraceptive programmes: a human rights analysis of existing quantitative indicators. Geneva: World Health Organization; 2014 (http://apps.who.int/iris/bitstream/10665/126799/1/9789241507493_eng. pdf, accessed 3 February 2016). 25. Ensuring human rights in the provision of contraceptive information and services: guidance and recommendations. Geneva; World Health Organization; 2014 (http://apps.who.int/iris/bitstream/10665/102539/1/9789241506748_ eng.pdf, accessed 27 January 2016). 3.2 Adolescent sexual and reproductive health 3.2.1 Introduction One of the key priorities for the work of the WHO Department of Reproductive Health and Research including HRP is adolescent sexual and reproductive health (ASRH). The range of related activities includes research (such as primary data collection, systematic reviews and secondary analyses), country-level support of monitoring and evaluation, and promoting implementation of evidence-based interventions. Ultimately this work contributes to improving access to sexuality education and sexual and reproductive health (SRH) services, including contraception, to promote healthy sexual development in adolescents and prevent SRH problems, such as early and unintended pregnancies. Major achievements • The Department’s three flagship adolescent research studies – ARMADILLO (providing ASRH messages through mobile phones), AHEAD (preventing rapid repeat pregnancy) and GEAS (understanding factors in early adolescence, including gender norms which are precursors to ASRH behaviours) – have completed their formative phases in multiple countries. — ARMADILLO: Activities for message development have been completed, and the messages are now being pilot-tested in Kenya. Formative activities for message development are under way in Peru. — AHEAD: Formative data collection has been completed to inform an intervention strategy in Ghana, and formative activities are under way in Malawi. — GEAS: Formative research has been completed at all 15 study sites and the toolkit face-validity and pilot-testing process has begun. • Country case studies of the policy and programmatic environment have been prepared in 10 countries and six of these were published as peer-reviewed journal articles. Thematic areas 35 3.2.2 Research and development 126.96.36.199 Intervention research (i) The AHEAD trial (Adolescent Health Experience after Abortion or Delivery): preventing rapid repeat pregnancy Progress The study protocol was published in Reproductive Health in November 2015 (1). Phase 1 has been completed in Ghana. During 2015, qualitative data were collected on adolescents, health-care providers and government officials relating to adolescents’ experiences of unplanned pregnancy and abortion in Ghana. The data collection took place in all three ecological zones throughout the country. A data analysis and project planning workshop was held in August 2015. Based on the results of this formative work, the team in Ghana believe that a renewed curriculum is needed for abortion providers in government health-care facilities – a curriculum that highlights the importance of giving post-abortion adolescents access to all contraceptive methods, including long-acting reversible contraceptives (LARCs), and the importance of ensuring that health-care facilities have these methods; a curriculum that will develop a cadre of trained health-care providers that will provide these services to adolescents. This intervention will be pilot-tested in phase 2 of the project. Planned activities • Malawi has drafted their protocol and data collection will occur at three health- care facilities in the country for phase 1 in early 2016. (ii) The ARMADILLO study (Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes) Progress The study protocol was published in Reproductive Health in August 2015 (2). Phase 1 data collection has been completed in Kenya. During 2015, draft messages were developed that were tested with young people and caregivers using focus group discussions. The data collection took place in and around Mtwapa, Kenya. The data are informing current work to finalize the messages. Additionally, Peru was identified as a second ARMADILLO country site. The protocol was adapted and received clearance from the Research Project Review Panel (RP2), WHO’s Ethics Review Committee (WHO- ERC) and the local Institutional Review Board (IRB). The formative work at three study sites across Peru was initiated at the end of 2015. Planned activities • In Kenya in 2016, the protocol will be developed for a randomized controlled trial (RCT) design to measure the impact of the messages developed for ARMADILLO. Outcomes will include knowledge, norms, self-efficacy and behavioural outcomes. • In Peru in 2016, the ARMADILLO messages will be developed and finalized based on the formative research. • Following the RCT, the Department will conduct a coverage study to assess the reach of ARMADILLO in both countries. (iii) GEAS (Global Early Adolescent Study) The Department is working with the Johns Hopkins School of Public Health to carry out a multinational longitudinal study of the social processes shaping young people’s Annual Technical Report 201536 health, with particular attention to the ways gender norms inform adolescent sexual health and behaviours in different contexts. The study is planned for implementation in two phases, taking place in sites in Belgium, Bolivia, Burkina Faso, China, the Democratic Republic of the Congo, Ecuador, Egypt, India, Kenya, Malawi, Nigeria, Scotland, South Africa, the United States of America (USA) and Viet Nam. Phase 1 of the study employs a mixed-methods approach for the creation of a toolkit that includes four new instruments assessing gender norms and sexuality, specifically for use among early adolescents worldwide. Progress In 2015, the formative component of phase 1 was completed at most sites, informing the development of a practical toolkit to be pilot-tested and validated in the latter half of phase 1 and used in a five-year longitudinal study in phase 2. The toolkit consists of: • The Gender Norms Scales – to assess beliefs about normative expressions of what it means to be a young adolescent boy or girl. • The Gender Equitability in Relationships Instrument – to assess gender biases in relationships. • The Health Instrument (10 modules) – to assess physical and mental health, healthy sexuality and sexual health, empowerment and related factors. • The Context Measure – to measure social cohesion, safety and security, risk and protective factors in the neighbourhood, from the perspective of the adolescent. Also in 2015, a systematic review to understand the factors that shape gender norms among young adolescents was finalized and submitted to a peer-reviewed journal. This systematic review is part of the efforts to understand how gender norms are shaped during the early adolescent period. It is a mixed-methods review of both quantitative and qualitative studies. The review highlights that norms related to sexuality are intensified when boys and girls attain puberty. These norms are shaped by peers, parents and schools. They vary for boys and girls as well as by their ethnicity, race and class. Planned activities • A special supplement of the Journal of Adolescent Health will be published in the second half of 2016 summarizing key findings from the over 900 narrative interviews that have been translated, transcribed, coded, analysed and synthesized into eight core themes and manuscripts. • In 2016, phase 1 will be completed and preparations for phase 2 will begin in earnest. Using the globally validated toolkit, a five-year longitudinal study of 1400 10- to 14-year-olds in each site will aim to generate empirical evidence linking gender norms to ASRH outcomes, explore the relationships between gender norms and social contexts, and contribute to evaluation of long-term consequences of programmatic efforts to change gender norms in early adolescence. • In 2016, it is expected that the systematic review on factors that shape gender norms among young adolescents will be published. 188.8.131.52 Systematic reviews and secondary data analyses As part of the work to strengthen the evidence base on the SRH of adolescents and diverse populations, several systematic reviews were carried out focusing on a range of outcomes. Thematic areas 37 (i) Systematic review on adolescent access to SRH commodities through pharmacies Progress A systematic review of the literature on adolescent access to SRH commodities through pharmacies found that limited evidence exists in the current literature. The majority of the available evidence focuses on adolescents’ experiences obtaining emergency contraception from pharmacies. Much of the evidence also focuses on misconceptions among both pharmacists and clients that better access to emergency contraception could result in increases in sexually risky behaviours and decreases in the use of other contraceptives. Overwhelmingly, the existing evidence does not support either of these views. Further, access for adolescents still remains a problem, largely because pharmacists act as gatekeepers, hindering adolescents’ ability to obtain SRH commodities even when policies or law are in place to promote access through pharmacies. Planned activities • A manuscript is currently under peer review for publication in 2016. (ii) Systematic review of provider-side barriers to access to contraception for adolescents Progress A systematic review of the literature on provider-side barriers to access to contraception among adolescents in low- and middle-income countries (LMICs) is under way. Following systematic searches of relevant databases, the search strategy identified 20 articles for inclusion, representing geographically diverse settings. Planned activities • The evidence from these 20 articles will be abstracted and analysed. • A manuscript will be written and submitted for publication to disseminate the findings. (iii) Systematic review of sexually transmitted infection (STI) services for adolescents and youth in low- and middle-income countries: perceived and experienced barriers to accessing care Progress The Department carried out this piece of work with the United States Centers for Diseases Control and Prevention (CDC). We conducted a qualitative systematic review of mixed- methods studies to assess views of adolescents and service providers on barriers that prevent adolescents from seeking appropriate STI services. We searched the peer-reviewed literature for studies published between 2001 and 2014 with a study population of young people (aged 10–24 years) and/or health-care providers. Nineteen studies from 15 countries met the inclusion criteria. We employed thematic analyses to identify key themes across the studies. Findings suggest that young people lacked knowledge about STIs and services. They experienced barriers related to service availability and accessibility because of a lack of integration of services. However, the most commonly reported barriers related to the acceptability of services. Young people reported avoiding services or having confidentiality concerns based on provider demographics and behaviours, such as rude or unfriendly treatment, blaming, lecturing or scolding. Further, experiences Annual Technical Report 201538 of shame and stigma were common barriers to seeking care. Adolescents in LMICs experienced significant barriers in obtaining STI services. Improving service uptake will require efforts to address clinic systems and provider attitudes, including confidentiality issues. Moreover, addressing barriers to STI services will require addressing cultural norms related to adolescent sexuality. Planned activities • A manuscript has been submitted to the Journal of Adolescent Health and is under review. This will be published in 2016 and then disseminated (iv) Community-based reproductive health interventions for young married couples in resource-constrained settings: a systematic review Progress The Department carried out a systematic review of community-based approaches used to deliver reproductive health interventions to young married couples in resource- constrained settings; this work was done in conjunction with the Health Institute for Mother and Child (MAMTA), and Indian nongovernmental organization (NGO). The systematic review included research studies and evaluation reports of different community-level initiatives to improve access to contraception, pregnancy care and safe abortion services for young married couples in which the women were in the age-group of 15–24 years. Of the 14 projects that met the inclusion criteria, eight also met the quality criteria and were thus included in the review: five from India, two from Nepal and one from Malawi. The analysis showed that community-based interventions consisting of counselling for young married women and their husbands, family and community members, as well as capacity-building of health workers, were effective in increasing contraceptive use, delaying pregnancy and improving pregnancy care. Stratifying young women in line with their specific reproductive health needs (i.e. newly married women, pregnant women, mothers of one or more children) and addressing their differing needs is a successful strategy. Notably, none of these projects explicitly addressed improving access to safe abortion care. The review, which was published in BMC Public Health in 2015, suggests that multi- layered community-based interventions, targeting young married women, their families and the health system can improve the utilization of reproductive health services among young couples in resource-constrained settings. The review also identified the need for further research to fill the knowledge gaps that exist about improving the utilization of reproductive health-care services, especially safe abortion care, among young married women in LMICs (3). Planned activities • This paper is feeding into our advocacy and support to countries, on employing evidence-based interventions to reach young married couples, which will continue during 2016. (v) Secondary data analysis of contraceptive use patterns among adolescents Progress Meta-regression analysis focusing on patterns of contraceptive use among adolescents is ongoing. This analysis uses Demographic and Health Survey (DHS) data from more Thematic areas 39 than 40 LMICs to explore proportions of adolescents in each country that (a) have never used a method of family planning, (b) have used a method but are not currently using one, (c) are currently using a method considered to be a least effective method (traditional methods), (d) are currently using a method considered to be effective (modern contraceptive methods excluding LARCs), and (e) are currently using a method considered to be the most effective (LARCs). These patterns of contraceptive use show a great range of experiences among adolescents across the many countries while also helping to illuminate potential points of intervention to determine reasons for non-use and for discontinuation and to encourage movement towards use of very effective methods. Planned activities • This analysis will be presented at the International Conference on Family Planning in Bali, Indonesia, in January 2016. • A manuscript will be submitted for publication in 2016. (vi) Meta-regression analysis of reasons for non-use of contraception among adolescents Progress An ongoing analysis using DHS data from more than 40 LMICs explores the reasons adolescents give for not currently using a method of contraception. These reasons include cost, barriers to access, and health concerns, including side-effects. Preliminary analysis suggests that there is a large degree of heterogeneity across countries among adolescents but that cost and barriers to access tend not to be highly prevalent reasons while health concerns and opposition to family planning, either on the part of the respondent or the respondent’s partner, are commonly cited reasons for non-use and for not intending to use a method in the future. Planned activities • A manuscript will be submitted for publication in 2016. (vii) Meta-regression analysis of adolescent access to contraception through pharmacies Progress To complement the above-mentioned systematic review on pharmacy provision of SRH commodities to adolescents (see item [i] in this sub-section), secondary data analyses using DHS data are under way focusing on pharmacy use by adolescents in a broad range of LMICs. Preliminary results suggest that there is wide variety in the proportion of adolescents obtaining contraceptive methods from pharmacies. Planned activities • A manuscript will be submitted for publication in 2016. (viii) Secondary data analysis of first births in very young adolescents in three East African countries The Department carried out this piece of work in collaboration with the University of Southampton, United Kingdom. Beginning in 2014, we analysed adolescent first births using disaggregated DHS data for three East African countries: Kenya, Uganda and the United Republic of Tanzania. We produced cross-sectional descriptive data on adolescent Annual Technical Report 201540 motherhood by age-group (under 16, 16–17 and 18–19 years), marital status, wealth, education, state or region, urban/rural residence and religion. We then analysed trends for two or more DHS surveys conducted within the same country over a period of 18–23 years, and again disaggregated the data by age, wealth, urban/rural residence and marital status to ascertain which groups within the population have benefited most from reductions in adolescent first births. In order to adjust for confounding factors, we used multinomial logistic regression to analyse the social and economic determinants of adolescent first births, with outcomes again stratified by age. Progress Our analysis showed that in the three countries, a significant proportion of women gave birth before age 16 (7%–12%). Both the bivariate analysis and logistic regression showed that adolescent motherhood is strongly associated with poverty and lack of education/ illiteracy, and this relationship is strongest among births within the youngest age group (< 16 years). There were also marked differences by region, religion and urban/rural residence. Trends over time showed that there has been limited progress in reducing adolescent first births overall, with no reductions among the poorest. Adolescent first births, particularly at the youngest ages, are most common among the poorest and least educated, and no progress has been made in reducing rates within this group over the last few decades. The report on this analysis was published in 2015 in Reproductive Health(4). The Department has used the report to advocate for segmenting adolescent populations and disaggregating adolescent data to better inform policies and programmes. In order to facilitate the use of these data by policy-makers and programme managers at both national and subnational levels, the Department continued to work with the University of Southampton, United Kingdom, to explore ways of presenting information on first births in young adolescents and the contexts in which these births occur, using geospatial methods. A paper describing this is being prepared. The Department–Southampton University team has now started analysing levels and trends of first births in adolescents, in selected Latin American countries. Planned activities • The paper on first births in young adolescents, presented using geospatial methods, will be submitted for publication in 2016. • Building on the work done on Africa, the Department–Southampton University team intends to analyse levels and trends of first births in adolescents, in selected South-East Asian and Latin American countries. (ix) Adolescent-friendly health services in low- and middle-income countries: a scoping review Progress In 2015, the Department published a review of the effectiveness of approaches to improve the provision and utilization of health services in LMICs. Only a small number of study reports and evaluation reports met the review’s inclusion criteria. Hence, the review did not fully represent the nature and scope of the work that has been and is being carried out in LMICs. To fill this gap, we have carried out a complementary systematic review of adolescent-friendly health services in LMICs. Our review seeks to answer three questions: • How have initiatives in LMICs defined making health services friendly for adolescents? Thematic areas 41 • What activities have been carried out by these countries to make health services adolescent-friendly? • How have these initiatives monitored and evaluated their work? Planned activities • In 2016 the Department will finalize the review and submit it for publication. • The findings will be used in the Department’s advocacy and country support work. (x) Approaches used to improve and maintain improvements in the performance of health workers: a systematic review Previous reviews, including one published by the Department in 2015, have shown that a competent and friendly health worker is critical to an adolescent-friendly health service. Given this, building the capacity and the attitudes of health workers to respond to adolescents effectively and with sensitivity is a key component of almost all efforts to make health services adolescent friendly. Progress In order to determine whether evidence-based approaches are being used to achieve this, we are carrying out a systematic review of approaches used in LMICs to improve and maintain improvements in the capacity of health workers to respond effectively and with sensitivity to adolescents. Planned activities • In 2016 the Department will finalize the review and submit it for publication. • The findings will be used in the Department’s advocacy and country support work. 3.2.3 Monitoring and evaluation 184.108.40.206 Analysing the adolescent content of national contraceptive policies, strategies and guidelines using the Department’s guidelines on ensuring human rights in the provision of contraceptive information and services In 2014, the Department initiated an exercise to examine whether national contraceptive policies, strategies and guidelines: • require health workers to provide contraceptive information and services to adolescents; and • require the relevant authorities to build health workers’ competencies and attitudes, provide them with ongoing support, assess their performance and hold them accountable. Progress The Department’s work began with South Africa. The team set out to evaluate whether the updated South African national contraception policy and guidelines adequately address the needs of adolescents. Specific guidance for adolescents was found relating to six of the nine WHO summary recommendations and 11 of the 24 sub-recommendations. Adolescents are highlighted throughout the policy as being at risk for discrimination or coercion, and laws protecting the rights of adolescents are cited. Confidentiality of services for young people is emphasized, and youth-friendly services are described as a key element of service delivery. Areas to strengthen include the need for normative guidance Annual Technical Report 201542 ensuring both availability of contraceptive information and services for young people and adolescent participation in development of community programmes and services. A paper on this analysis has been published in 2015 in the Journal of Adolescent Health(5). Planned activities • Similar analyses have been initiated in the Philippines and Paraguay. • We intended to use these analyses to advocate for the removal of policy-level barriers on contraceptive provision to adolescents. 220.127.116.11 Quality assessment guidebook digitalization and implementation in Brazil In December 2013, the Department supported the creation of a prototype online/electronic version of WHO’s Quality assessment guidebook(6) that would allow for digital collection of data to assess the quality and friendliness of health services for adolescents. Starting in May 2014, in close collaboration with the Ministry of Health (MOH) in Brazil and Kenya-based developers Ona, the Department supported a Brazilian adaptation of the prototype website. This involved developing a Portuguese version of the existing online assessment tool, incorporating feedback from pilot-testing of the website and its user interface in Brazil, and developing various user profiles to reflect the different levels of the Brazilian health system (federal, state, municipality, etc.). Progress The Department organized a training session in April 2015 for implementers of the tool, after which phased roll-out commenced in five states of Brazil on a small scale. An integrated year-long research component was initiated, which will identify the optimal frequency with which the quality assessment tool should be implemented (including feedback from the tool to the facility) in states already selected for the phased roll-out. The roll-out was timed to coincide with the launch of the Agenda for the Protection and Care of Adolescents, a strategy to expand access to and quality of comprehensive care for adolescents nationwide. 6 The tool was implemented at the municipality level, with municipal teams responsible for periodically assessing clinics in their domains. Data were viewable at the facility level, to allow managers to see the teams’ progress. Data were also aggregated and viewable at the municipality, state and federal levels. Planned activities • Data collection will be completed by the end of the third quarter of 2016. Through this process, the Department will support the MOH in Brazil to analyse incoming data in order to monitor progress across and within the five states, and to identify the optimal monitoring period to implement in the context of the nationwide roll-out. • At the same time, the Department will work with the MOH and technology partners to plan and implement a controlled scale-up across Brazil. 6 Further information is available at: http://ehnunes.com/adolescentes/abertura.html Thematic areas 43 18.104.22.168 Post-hoc evaluation of the CERCA Project, a multicomponent intervention to promote ASRH in three Latin American countries: a qualitative post-hoc evaluation From 2011 to 2014, with funding from the European Union, the International Centre for Reproductive Health (ICRH) at the University of Ghent, Belgium, carried out an intervention study entitled “Community-embedded reproductive health care for adolescents” (CERCA) in Bolivia, Ecuador and Nicaragua, to test the effectiveness of a combination of interventions preventing teenage pregnancies. The outcome evaluation showed limited impact. In this context, ICRH and the Department agreed to carry out a post-hoc process evaluation to determine if and how CERCA’s design, implementation, monitoring and evaluation contributed to the disappointing results. Progress Findings from the post-hoc evaluation resulted in the following lessons learnt for future projects: • Projects like CERCA should begin with a preparatory phase in which a thorough analysis of the situation is carried out, which feeds into intervention design. A targeted and context-specific theory of change should be developed before the start of an intervention study. Such a theory should set out the individual and environmental determinants to be targeted, the interventions to be employed and the inputs, processes, outputs and outcomes to be measured, when and how they are to be measured and how the gathered data are to be used. • If the intervention design is modified in any way, there should be corresponding changes in the measurement framework, and all changes should be meticulously documented. • Accepting teenage pregnancies as a complex issue means that not only must the interventions be tailored to this complexity, but so must the evaluation design. In the case of multicomponent projects like CERCA, a specific evaluation approach should be developed for each activity (e.g. workshops, mobile consultancies, helpline), and data should be collected on their effectiveness, as well as on feasibility and acceptability, and on factors that help and hinder (7). A manuscript has been submitted for publication. Planned activities • In 2016, the Department will continue to build a portfolio of evaluations of programmes and projects that are being implemented in LMICs to complement the lessons being learnt from prospective studies. 22.214.171.124 Strengthening the collective response of the government to end child marriage through a district-level convergence approach in Jamui, Bihar and Sawai Madhopur, Rajasthan, India The Health Institute for Mother and Child (MAMTA) is an Indian NGO active in the ASRH field since 1990. Between 2011 and 2015, MAMTA in partnership with district administrations undertook a project to support the development and testing of a government-led, cross-departmental convergence approach to ending child marriage in Sawai Madhopur District, Rajasthan, and Jamui District, Bihar. After three years of implementation, MAMTA approached the Department to evaluate the project. Annual Technical Report 201544 The evaluation sought to answer the following questions: 1. How has the MAMTA project contributed to the establishment of concerted sectoral and intersectoral district-level efforts to prevent child marriage? 2. Did these efforts lead to more concerted actions at the block, panchayat and village levels? 3. What were the critical factors that contributed to these changes, at the individual and institutional levels? Progress The evaluation described how the project was designed, implemented and monitored (and how this related to the plan), and what was achieved at the state, district, block, gram panchayat and village levels. It also proposed recommendations for MAMTA to consider when undertaking efforts to expand or replicate this work (8). Planned activities • In 2016, the Department will share the findings and recommendations of the evaluation in India and in the global child marriage prevention community. • Additional research will also be undertaken in this area. 126.96.36.199 Drawing lessons from the first generation of the scale-up of adolescent sexual and reproductive health (ASRH) programmes At the International Conference on Population and Development (ICPD) in Cairo in 1994, governments committed to promoting the sexual and reproductive health of adolescents through policies and programmes, with varying results to date. In many countries, these efforts do not contain all three of the following components: providing sexuality education; providing SRH services; and creating a safe and supportive environment. There are a number of LMICs where scaled and sustainable government-led efforts are under way. Not all of these government-led programmes implement activities in all three components as noted above. Having said this, each of these “first generation” of scaled up ASRH programmes represents a success and offers important lessons on what it took to overcome the obstacles that have prevented so many other countries from achieving scale. Progress In 2015, the Department documented (or initiated documentation of) case studies in: Argentina, Brazil, Colombia, Estonia, India, Mongolia, Mozambique, Nigeria, Pakistan and Senegal. Papers relating to Estonia, Mozambique, Pakistan and Senegal were published during the course of the year (9–12). Planned activities • These case studies will feed into a global meeting to be held in Geneva in April 2016, whose first objective will be to draw out the lessons learnt from the LMICs present which have scaled up ASRH programmes, highlighting both commonalities and specificities in each context, and achievements as well as challenges. The second objective will be to strategize on how the experiences gained from the first generation of scale-up could inform the second generation of programmes that are being initiated in a number of countries. Thematic areas 45 3.2.4 Dissemination and partnerships 188.8.131.52 Dissemination of research evidence Progress In January 2015, the Department published a special supplement to take stock of progress in adolescent health, 20 years since the ICPD. The special supplement to the Journal of Adolescent Health contains five papers reviewing research evidence, implementation experience and an overview (13). During the course of the year, the Department worked with USAID and UNFPA to publish a complementary paper, which conveyed the following two key messages: • We must ensure the implementation of interventions that have been shown to be effective, with fidelity to the methods and adequate dosage. • We must avoid implementing ineffective interventions that waste human and financial resources, and raise questions about the value of policies and programmes that do not demonstrate results (14). The Department shared the key messages emanating from the special supplement through global launch events that took place at the end of 2014 and in early 2015, as well as a sustained online and media promotion campaign, while also presenting the findings at key global conferences including the 3rd Asia Population Association Conference (Kuala Lumpur, Malaysia; July 2015) and the International Federation of Gynecology and Obstetrics (FIGO) World Congress (Vancouver, Canada; October 2015). The Department worked with the WHO Regional Office for Africa to organize a three-day workshop on the special supplement, which brought together about 35 participants including MOH staff, staff of WHO country and regional offices, and representatives of other UN agencies. Plans are under way to organize a similar workshop in the WHO South-East Asia Region early in 2016. At the invitation of the Swiss Agency for Development and Cooperation (SDC), a member of the Department’s Adolescents and at-Risk Populations team presented a talk at a TEDx event held in Chisinau, Moldova, in May 2015, on the subject of “Why we shouldn’t shy away from sexuality education”. 7 The video has been accessed nearly 10 000 times since it was launched in September 2015. Planned activities • In 2016, the Department will continue to communicate the lessons learnt from our review of research evidence and programmatic experience to help ensure that ASRH programmes are informed by this evidence and experience. 184.108.40.206 Feeding into the work of others The Department’s evidence synthesis on adolescent-friendly health services has fed into the development of guidelines on this subject by WHO’s HIV Department and is feeding into guidelines being developed by WHO’s Maternal, Newborn, Child and Adolescent Health Department. 7 Video available at: https://goo.gl/XNgKmj Annual Technical Report 201546 Progress Over the year, Department staff contributed to consultative processes, including the adolescent component of the revised Global Strategy for Women’s, Children’s and Adolescents’ Health (led by UNFPA), the General Comment on adolescent development (led by UNICEF), the work of the Inter-Parliamentary Union in engaging governments to address child, early and forced marriage (CEFM), and the resolution on CEFM at the 29th Human Rights Council meeting in 2015 (15). Planned activities • In 2016, the Department will continue to work in conjunction with other relevant departments at WHO and with partner organizations within and outside the UN system towards our shared goals. 220.127.116.11 Capacity-building The Department contributed to strategy development and to capacity-building. For example: • In February 2015, the Department was invited to contribute to Jhpiego’s “Global summit on key insights and transformative solutions on access, uptake and quality of sexual and reproductive health care for adolescents”. • In March 2015, the Department made significant contributions to a “Day of learning” organized by the David and Lucile Packard Foundation for its global staff team. As in previous years, the Department coordinated a module on ASRH in the Geneva Foundation of Medical Education and Research’s e-course, “Research capacity- strengthening in sexual and reproductive health”; the Department also worked with the Foundation’s staff to evaluate the effects of the course on the participants. Planned activities • In 2016, the Department will continue to use a variety of means to build country capacity in planning and implementing ASRH programmes. 18.104.22.168 Country support Progress During the course of the year, Department staff provided support to: • Myanmar, for the development of an updated national strategy on adolescent health; • India, for a national technical working group to guide the implementation and monitoring of its National Adolescent Health Programme; • Bangladesh, to strengthen political leadership in child marriage prevention. Planned activities The Department also worked with the Bill & Melinda Gates Foundation to secure funding to strengthen the provision of contraceptive information and services to adolescents. This work will be initiated in 2016 in 10 African countries in five areas: i. Prepare country-specific policy briefs to advocate for action based on secondary analyses of: — data on demand and met/unmet need for contraception; Thematic areas 47 — data on barriers to access and uptake of contraception by different groups of adolescents; — national contraceptive policies, strategies and guidelines. ii. Build capacity in service provision using a variety of WHO tools. iii. Build capacity in monitoring and using monitoring data. iv. Advocate for attention to adolescents in proposals and plans. v. Provide support for documentation. 3.2.5 References 1. Hindin MJ, Rodriguez MI, Gonsalves L, Say L. Adolescent health experience after abortion or delivery (AHEAD) trial: formative protocol for intervention development to prevent rapid, repeat pregnancy. Reprod Health. 2015;12(1):111. 2. Gonsalves L, L’Engle K, Tamrat T, Plourde KF, Mangone ER, Agarwal S, Say L, Hindin MJ. Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) Study: Formative protocol for mHealth platform development and piloting. Reprod Health. 2015;12:67. 3. Sarkar A, Chandra-Mouli V, Jain K, Behera J, Mishra S, Mehra S. Community based reproductive health interventions for young married couples in resource- constrained settings: a systematic review. BMC Public Health. 2015;15:1037. doi:10.1186/s12889-015-2352-7. 4. Neal SE, Chandra-Mouli V, Chou D. Adolescent first births in East Africa: disaggregating characteristics, trends and determinants.Reprod Health. 2015;12:13. doi:10.1186/1742- 4755-12-13. 5. Hoopes A, Chandra-Mouli V, Steyn P, Shilubane T, Pleaner M. South Africa: an analysis of adolescent content in South Africa’s contraception policy using a human rights framework. J Adolesc Health. 2015;57:617e623. 6. Quality assessment guidebook: a guide to assessing health services for adolescent client. Geneva: World Health Organization; 2009 (http://apps.who.int/iris/ bitstream/10665/44240/1/9789241598859_eng.pdf, accessed 28 January 2016). 7. Ivanovo O, Cordova Pozo K, Segura ZE, Vega B, Chandra-Mouli V, Temmerman M et al. Lessons learnt from the CERCA Project, a multicomponent intervention to promote adolescent sexual and reproductive health in three Latin America countries: a qualitative post-hoc evaluation. (Submitted for peer review). 8. Report of an evaluation of the project: Collective Response of the Government to End Child Marriage Through a District Level Convergence Approach in Jamui, Bihar and Sawai Madhopur, Rajasthan, India. World Health Organization, Department of Reproductive Health and Research; 2015 (unpublished report). 9. Kempers J, Ketting E, Chandra-Mouli V, Raudsepp T. The success factors of scaling-up Estonian sexual and reproductive health youth clinic network: from a grassroots initiative to a national programme 1991–2013. Reprod Health. 2015;12(2):1–9. doi:10.1186/1742-4755-12-2. 10. Chandra-Mouli V, Gibbs S, Badiani R, Quinhas F, Svanemyr J. Programa Geracao Biz, Mozambique: how did this adolescent health initiative grow from a pilot to a national programme, and what did it achieve? Reprod Health. 2015;12(12). Annual Technical Report 201548 doi:10.138.186/1742-4755-12-12. 11. Svanemyr J, Baig Q, Chandra-Mouli V. Scaling up of life skills based sexuality education in Pakistan: a case study. Sex Education. 2015;15(3):249–62. doi:10.10 80/14681811.2014.1000454. 12. Chau K, Traoré Seck A, Chandra-Mouli V, Svanemyr J. Scaling up sexuality education in Senegal: integrating family life education into the national curriculum. Sex Education. 2016. doi:10.1080/14681811.2015.1123148. 13. The International Conference on Population and Development. Special supplement to J Adolesc Health. 2015;56(1):Suppl S1–S60 (http://www.jahonline.org/issue/S1054- 139X(14)X0004-2, accessed 3 February 2016). 14. Chandra-Mouli V, Lane C, Wong S. What does not work in adolescent sexual and reproductive health: a review of evidence on interventions commonly accepted as best practices. Global Health: Science and Practice. 2015;3(2):333–40. 15. Strengthening efforts to prevent and eliminate child, early and forced marriage. Human Rights Council, Twenty-ninth session, 1 July 2015. UN General Assembly (A/HRC/29/L.15; http://daccess-dds-ny.un.org/doc/UNDOC/LTD/G15/139/78/ PDF/G1513978.pdf?OpenElement, accessed 27 January 2015). 3.3 Maternal and perinatal health 3.3.1 Introduction The maternal and perinatal health programme of work follows carefully selected priorities that are based on global priorities, as well as the strengths and capacity of the team and its networks. The Sustainable Development Goals (SDGs) launched in 2015 prioritized maternal and newborn targets for the next 15 years. These targets and the priority themes of “Survive-Thrive-Transform” will guide our work in the coming years. The programme’s focus in recent years puts it in a strong position to address the new challenges. Following the conclusion of the WHO Multi-Country Survey on Maternal Severe Morbidity and several secondary analyses in 2014–2015, the programme prioritized the areas of intrapartum care and caesarean section. These two priorities were addressed through the ongoing Better Outcomes in Labour Difficulty (BOLD) project and a number of systematic reviews and analyses on the rates of caesarean section. The WHO Statement on caesarean section rates published in April 2015 addressed this global challenge (1). The work on mistreatment of women during childbirth and maternal severe morbidity formed the basis for the development of the new WHO framework on quality of care for pregnant women and newborn babies around the time of childbirth, which was endorsed by the Scientific and Technical Advisory Group (STAG) in 2015 as a priority (2). With increased collaboration between the WHO Department of Reproductive Health and Research (RHR), including HRP, and the WHO Department of Maternal, Newborn, Child and Adolescent Health (MCA) in this area, the work gained significant momentum. Through this collaboration, WHO has taken a leading position globally in improving quality of care for women specifically around the time of childbirth, and for newborn babies. In addition to the quality-of-care work, the second priority area has been on preterm birth. The RHR Department has developed a significant portfolio of work on preterm birth in 2015 including a new grant from the Bill & Melinda Gates Foundation to Thematic areas 49 evaluate the efficacy of antenatal corticosteroids for women at risk of preterm birth in a multicountry randomized controlled trial (RCT). The global epidemiology work played an important role in the launching of the Global Strategy for Women’s, Children’s and Adolescents’ Health in September 2015 (3) and the subsequent publications of the global maternal mortality estimates in November (4, 5). The programme is developing global preterm birth estimates to be published in 2016. The programme finalized the perinatal death classification and this will be published as The WHO application of International Classification of Diseases 10th revision (ICD-10) to perinatal deaths: ICD-PM (or “ICD-Perinatal Mortality”), a sister document to the ICD-MM (ICD-Maternal Mortality) (6); the ICD-PM also complements the Maternal death surveillance and response (MDSR) (7) and the perinatal death audit project, both of which are led by the MCA Department. In 2016–2017, the Department will develop key activities around maternal and early newborn sepsis and also on implementing the 2015 quality-of-care framework for pregnancy and childbirth. This framework conceptualizes quality of care for maternal and newborn health by identifying domains which should be targeted to assess, monitor and improve care within the context of the health system (2). It forms the basis for the development of quality standards and measures that will guide quality improvement for mothers and newborns within the context of the SDGs. Major achievements • The WHO framework on quality of care for pregnant women and newborns around the time of childbirth was published in BJOG. The quality statements and indicators for the eight domains focusing on both provision and experience of care were finalized. • The Department released the WHO statement on caesarean section rates, including information on optimal rates and monitoring of caesarean sections at facilities. This eagerly awaited statement superseded the earlier 1985 statement, which has been widely quoted. The new Statement emphasizes that while there seem to be mortality benefits up to national population level rates of 10%, much of the association can be explained by development status of the country. WHO recommends the 10-group Robson classification to monitor caesarean section rates. • An analysis of changes in caesarean section usage in 21 countries was published in Lancet Global Health. By combining data from the WHO Global Survey on Maternal and Perinatal Health and the WHO Multi-Country Survey on Maternal and Newborn Health, the paper demonstrated that the Robson classification can be applied to facility-level data in low- and middle-income countries (LMICs) for standardized comparisons of caesarean section data across countries and time points, and to identify subpopulations driving changes in caesarean section rates. • WHO recommendations on interventions to improve preterm birth outcomes (for mothers and newborns) were published. This brought much-needed international guidance following the publication of the large multicountry trial that cast doubt on the safety and efficacy of antenatal corticosteroids for women at risk of preterm birth in LMICs. In addition, the Department secured a grant from the Bill & Melinda Gates Foundation to conduct a randomized clinical trial in sub-Saharan Africa and South Asia to address an important research gap on this topic. • WHO recommendations for prevention and treatment of maternal peripartum infections were launched during the International Federation of Gynecology and Obstetrics (FIGO) Annual Technical Report 201550 World Congress in Vancouver, Canada. The recommendations mainly address preventive interventions and can be seen as a springboard for the maternal and early newborn sepsis initiative that will be launched in 2016. • The mistreatment of women during childbirth in health facilities globally: a mixed-methods systematic review was published in the journal PLoS Medicine, with extensive international media coverage. The review, which was based on data from 34 countries, suggested that mistreatment of women during childbirth is widespread globally. • Estimates of maternal mortality for the period 1990–2015 were published as a peer- reviewed paper in The Lancet and as a full Interagency report. It is estimated that 303 000 maternal deaths occurred during 2015 and that there has been a 44% decline in the maternal mortality ratio (MMR) since 1990, falling short of the Millennium Development Goal (MDG) to reduce it by three quarters. These estimates will serve as the baseline for SDG target 3.1: by 2030 reduce the global MMR to less than 70 per 100 000 live births. 3.3.2 Research and development 22.214.171.124 Improving quality of care for mothers and newborns (i) Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial Antenatal care (ANC) visits constitute one of the few times when women in many resource-poor settings seek care for their own health. Therefore, they represent an important opportunity for reaching women with a number of interventions that may be vital for their health and the health of their unborn child. The Department is conducting a facility-based cluster RCT with a “stepped wedge” design in Mozambique by implementing an intervention targeted at increasing the delivery of evidence-based practices included in the ANC package delivered by midwives and promoting the integration of key interventions into routine ANC. The ultimate goal is to improve maternal and newborn outcomes as well as the detection, treatment and prevention of major health-related conditions in pregnant women. The intervention includes the provision of kits with all necessary medicines and laboratory supplies for ANC, a storage system, a tracking system, and training sessions for health-care providers. Progress On 2 June 2014, the Department successfully launched the intervention in the first health-care facility. Since then and during 2015, the intervention has been rolled out in a new facility every two months in accordance with the study design. The 10th facility entered the intervention in December 2015 and data collection is scheduled to end on 31 January 2016 including more than 230 000 ANC visits. The results of the formative research were published in September 2015 in BMC Pregnancy and Childbirth (8). The 2014 Annual Steering Committee meeting recommended introducing a women’s satisfaction survey and this was conducted in July 2015. Planned activities • In 2016, upon finalizing data collection, the database will be prepared for the analysis and subsequently analysed according to the planned data analysis protocol. Preparation of manuscripts reporting the results of the RCT will follow. Thematic areas 51 • The Department plans to continue engaging with stakeholders and other institutions that are playing a role in advancing maternal and infant health in Mozambique, to discuss the implications of this project should the results prove that the intervention is effective. In particular, the necessary next steps should be discussed, including plans of the Ministry of Health (MOH) to potentially scale up the use of the intervention in the country, if deemed appropriate. • The Department envisions maintaining and strengthening the research capacity built in Mozambique to contribute to future research in the country and other African countries. (ii) Multicountry study to develop fetal growth standards The Department completed a multicountry study to develop fetal growth standards for international application, by assessing fetal growth under nutritionally unrestricted conditions in populations of different ethnic and geographic backgrounds. The study included 1439 pregnant women from 10 countries with different ethnic and geographic backgrounds. Results of this study will have important clinical and research implications for the prenatal and postnatal periods, as well as for maternal health. Progress During 2015, the study’s dataset was analysed and growth curves were fitted to the data to develop fetal growth standards, taking into account ethnic and geographic differences. Planned activities • The manuscript will be submitted for publication in February 2016. (iii) Better Outcomes in Labour Difficulty (BOLD) Complications arising during labour and childbirth account for a significant proportion of the global burden of maternal and newborn mortality and morbidity, particularly in LMICs. Yet, the quality of intrapartum care for women who access care in many health- care facilities in low-resource settings remains suboptimal. The Department initiated the BOLD project to accelerate the reduction of intrapartum-related maternal, fetal and newborn mortality and morbidity by addressing the weaknesses in the process of labour care and bridging the disconnect between the health-care facilities and the communities in low-resource settings. The project aims to achieve this goal through a two-pronged approach: (a) by developing a “Simplified, Effective, Labour Monitoring- to-Action” tool (SELMA) that will assist health-care providers to monitor labour and decide on appropriate actions more efficiently; and (b) by developing innovative tools and service prototypes (termed “Passport to Safer Birth”), co-designed by women, community groups and health-care providers, to enhance access to respectful, quality care for pregnant women at the time of birth. The goal of the project is to integrate these tools (SELMA and Passport to Safer Birth) into a quality improvement approach that can be tested in a multicountry intervention research project. Progress The project started with a technical consultation of the Steering Committee and the Technical Advisory Group in February 2014. Following ethics and administrative approval of the study protocols by WHO and the participating hospitals, data collection for the clinical cohort for the development of SELMA was conducted in 13 hospitals in Nigeria and Uganda between December 2014 and November 2015. Data collection for the qualitative and service design research for development of Passport to Safer Birth Annual Technical Report 201552 began in December 2014 and was completed in June 2015. Two study protocols (cohort and formative research) and a commentary were published in BMC Reproductive Health in May 2015 (9, 10, 11). Since January 2014, a bi-monthly project newsletter has been published and disseminated to the project partners and researchers.8 A critical aspect of BOLD formative research is the identification of childbirth practices that are evidence-based, feasible to deliver by the health system and yet align with the values and preferences of pregnant women and their families. These practices, termed the “negotiated standards of care”, are intended to underscore the importance of providing humane and respectful care while maintaining high ethical and safety standards in clinical practice, and are an integral component of the Passport to Safer Birth. The Department participated in a series of workshops in Nigeria and Uganda in October and November 2015 to mediate the development of these standards by health-care facility administrators, health-care providers, women and community members. The development of these standards was guided by the WHO quality of care framework for maternal and newborn health and informed by the findings of qualitative data from the study populations, as well as internationally accepted best practices. The third technical consultation of the Steering Committee took place in December 2015 to discuss the preliminary results of the cohort, qualitative and service design research, and to initiate plans for the next phase of the project. Planned activities • Analysis of the qualitative and service design components of the research is ongoing and the development of service prototypes and tools for the Passport to Safer Birth is expected to be completed by the first quarter of 2016. Manuscripts reporting on the qualitative and service-design components of the project will be prepared and submitted for journal publication by the end of the second quarter of 2016. • Statistical and computational analysis for the development of early prototypes of SELMA will start in mid-January 2016 and are expected to be complete by the end of the second quarter of 2016. A preliminary review of the outputs of these activities will be conducted at a technical consultation of computational statisticians and artificial intelligence experts that will be held at WHO by the end of the second quarter of 2016. • Subject to expected outputs from phase I of the BOLD project, the Department will work with partners to conceptualize and develop the BOLD quality improvement (QI) strategy that integrates SELMA and Passport to Safer Birth. In consultation with the Bill & Melinda Gates Foundation, this activity will be followed by the development and finalization of a research proposal to test the effectiveness of the BOLD QI strategy through a multicountry intervention research project in the last quarter of 2016. (iv) How women are treated during facility-based childbirth: development and validation of measurement tools in four countries Every woman has the right to dignified treatment and respectful care during pregnancy and childbirth. Recent evidence has demonstrated that, globally, many women experience disrespectful or abusive treatment during labour and delivery in health- care facilities, which can pose a significant barrier to women presenting to facilities for delivery (12). Disrespectful and abusive treatment during childbirth may also result 8 Available at: www.boldinnovation.org Thematic areas 53 in poorer health outcomes for women and newborns. Recent efforts to define and measure disrespect and abuse have resulted in highly variable estimates of prevalence. Despite the growing recognition of this important public health problem (13), no effort has been made at the global level to define and measure its prevalence. This mixed-methods, two-phased study in four countries aims to develop and validate evidence-based tools so mistreatment can be accurately identified and measured. The primary objectives of this study are: • To develop an evidence-based definition of and identification criteria for mistreatment of women during childbirth in facilities, which can be used globally; • To develop and validate tools for measuring mistreatment of women during childbirth in facilities; • To explore individual, provider, institutional and health systems factors that either promote or prevent mistreatment of women during childbirth in facilities. Progress Phase 1 (formative phase) includes a mixed-methods systematic review on the mistreatment of women during childbirth in health-care facilities, which was published in the journal PLoS Medicine(14), with extensive international media coverage. Phase 1 data collection (four countries) is nearly completed and data analysis will be completed in early 2016. The study protocol (phase 1) was published in Reproductive Health in July 2015 (15). A commentary entitled “Promoting respect and preventing mistreatment during childbirth” was also published in BJOG in 2015 (16). Phase 2 (measurement phase) will be conducted in early 2016 in four countries. A review of related measurement tools has been completed to identify existing items. The measurement tools are currently being constructed, based on the mixed-methods systematic review, findings from phase 1 and the review of existing measures. Planned activities • Mistreatment of women during childbirth can also constitute a violation of women’s human rights. Work commenced in 2015 and will be completed in 2016, including an analysis of international human rights standards and agreements, to determine how the mistreatment of women in obstetric settings relates to (and violates) these. • To complement the mixed-methods review of mistreatment, and related to the team’s work on quality of care, a qualitative evidence synthesis of respectful maternity care was initiated in 2015 and will be completed in 2016. Definitions and behaviours identified in the course of this review will also be incorporated into the measurement phase of the research study. • Phase 2 will commence in February 2016 and be completed by August 2016. (v) Companion of choice around the time of childbirth Women have traditionally been attended by a companion during labour but the move to increasing institutional childbirth has not necessarily facilitated the continuation of this tradition. Having a companion of choice has been shown in a systematic review to improve outcomes for women in labour (17), yet this basic, well proven intervention is far from universal. There is also a global mandate to improve the quality of maternal and newborn care and a programme that increases the use of a companion of choice Annual Technical Report 201554 during labour is a clear response to WHO’s call to “initiate, support and sustain programs designed to improve the quality of maternal health care, with a strong focus on respectful care as an essential component of quality of care” (13). Progress To address this gap, WHO convened a technical consultation on “Companion of choice around the time of childbirth” on 11–12 August 2015. The aims of this meeting were: • to explore measures related to a companion of choice as part of a quality-of- care framework; • to discuss a generic protocol for implementation research (IR) to develop a model for implementation in LMICs and plans for scaling up; • to discuss activities at the regional and global levels to support and monitor implementation at the national level. Planned activities • The Department will develop a generic protocol to address context-specific and relevant design and evaluation of interventions and implementation strategies for companion of care around the time of childbirth. • The Department will undertake a synthesis of qualitative evidence entitled “Perceptions and experiences of labour companionship: a qualitative evidence synthesis”. • The Department will undertake an update of the Cochrane effectiveness review entitled “Continuous support for women during childbirth”. • The Department will develop evidence and policy briefs on labour companionship. (vi) WHO near-miss approach for improving quality of care for severe maternal complications The concept of “maternal near-miss”, indicating very severe maternal morbidity, has evolved over the past two decades. In 2009, a WHO Working Group defined maternal near-miss morbidity as “a woman who nearly died but survived a complication that occurred during pregnancy, childbirth, or within 42 days of termination of pregnancy” (18). This definition has been used to develop an instrument for assisting health-care facilities specifically, and health systems more broadly, to evaluate and improve quality of care using a criterion- based clinical audit approach; this instrument has been used in a number of countries (18). Progress (a) WHO Multicountry Survey on Maternal and Newborn Health The WHO Multicountry Survey on Maternal and Newborn Health was a cross- sectional, facility-based survey conducted from May 2010 to December 2011. The multicountry survey (MCS) aimed to assess the management of severe maternal complications and the prevalence of maternal near-miss cases. It captured information on over 314 000 women at 359 facilities across 29 countries in five WHO regions (19). The MCS is the largest study of its kind to show that high coverage of effective evidence- based interventions in health-care facilities does not ensure good outcomes. This finding puts the emphasis on improving the quality of care by ensuring that care is not only effective but also delivered in a timely and efficient way, ensuring that it is safe, equitable and people-centred. Thematic areas 55 We have continued to develop and publish new secondary analyses related to data from the MCS, as well as combining the dataset with data from the earlier, similar WHO Global Survey on Maternal and Perinatal Health to conduct more sophisticated longitudinal analyses. Since the completion of the study, 22 papers have been published in peer- reviewed journals, with an additional six papers currently under peer review. Five of those papers were published during 2015 (20–24). (b) Nigeria Near-miss and Maternal Death Survey In addition to the MCS, the Department also supported the Nigeria Near-miss and Maternal Death Survey, which was conducted in 2012–2013. This survey was a large, cross-sectional study that investigated the incidence of severe maternal complications in a nationwide surveillance network of tertiary health-care facilities in Nigeria. The objectives were to create a data system that networks all Nigerian tertiary institutions to periodically conduct a review of the magnitude of maternal near-miss and maternal death; the nature of events responsible for near-misses and maternal deaths; the indices for the quality of care for severe obstetric complications; and the health service events surrounding these complications. It is hoped that this will assist in collectively defining and monitoring the standard of emergency obstetric care at this level of health-care delivery in a country with high maternal mortality. The study prospectively collected information on all women admitted for delivery or within 42 days after delivery or termination of pregnancy who experienced life-threatening complications in 42 tertiary health-care facilities across all geopolitical zones in Nigeria for one year. Each study facility completed a 12-month surveillance between 1 June 2012 and 14 August 2013. The study represented the first opportunity to initiate a sound and reliable quantitative system for gathering data on severe maternal morbidities and maternal deaths in Nigeria. During the year-long study, there were 91 724 live births, 5910 stillbirths, 998 maternal deaths (excluding 136 mothers who died before arriving at the hospital), and 1451 maternal near-misses (based on WHO near-miss criteria) in the participating health- care facilities. The study highlighted several bottlenecks in the provision of care where improvement could make a difference to maternal survival. The main results of the study have been published in BJOG in May 2015 (25). The publication was well disseminated to the relevant stakeholders in Nigeria, and globally to over 10 000 maternal, newborn and child health experts. (c) Implementing the WHO near-miss approach A technical consultation was held in Istanbul, Turkey, on 22–23 January 2015, titled “WHO maternal near-miss approach and quality of care: research and implementation”. The objectives were to examine the evidence regarding the effectiveness, applicability and acceptability of the WHO maternal near-miss approach for all of the major causes of severe maternal morbidity and mortality, and to identify strategies to implement the maternal near-miss approach on a large scale. Meeting attendees included experts from 16 countries and WHO colleagues from different regions and departments. In discussing WHO’s past, current and future work in shifting focus to maternal morbidity, the meeting highlighted the intersection between implementing the maternal near-miss approach on a large scale, including near-miss monitoring at national levels, and WHO’s evolving framework on quality of care for maternal and newborn health. Examining the evidence and experience from the field, this meeting also helped to inform WHO’s developing quality of care agenda as the Department works to formulate an updated version of the maternal near-miss approach. Annual Technical Report 201556 Planned activities • Several more secondary analyses of the MCS data are currently under review by journals or are ongoing. • The manuscripts based on six secondary analyses of the Nigeria Near-miss and Maternal Death Survey dataset will be submitted for publication as a journal supplement. • Based on the evidence synthesis and technical consultation, the near-miss approach guide (18) will be updated in alignment with WHO’s work on improving quality of care for women and newborns. • A systematic review on “Applicability of the WHO maternal near-miss approach in low- and middle-income countries” will be published. (vii) Maternal morbidity measurement To fulfil the need to measure and respond to the full burden of maternal morbidity, WHO initiated a four-year project, funded by the Bill & Melinda Gates Foundation, to improve the scientific basis for defining, measuring and monitoring maternal morbidity. This project aims to construct a definition and develop identification criteria for maternal morbidity, estimate the burden of individual causes or determining factors of maternal morbidity based on existing evidence, develop and test an assessment tool for measuring maternal morbidity in LMICs, and develop indicators for maternal morbidity. On the basis of the background scoping exercise (26) and building upon the WHO definitions of health (27) and maternal mortality (28), the Maternal Morbidity Working Group (MMWG), by consensus, agreed on the definition for maternal morbidity and associated disability as “any health condition attributed to and/or complicating pregnancy and childbirth that has a negative impact on the woman’s wellbeing and/or functioning” (29). This broad definition recognizes the impact that morbidity may have on different dimensions of health, beyond physical health, and seeks to encompass the totality of a woman’s sense of well-being. Based on this definition, the MMWG developed identification criteria that served as the basis for the development of a maternal morbidity measurement tool. Progress (a) Estimate the burden of individual causes The lead authors of six systematic reviews related to the maternal morbidity project were invited to Geneva to give presentations on the progress of their reviews. The reviews address a wide range of topics pertaining to maternal morbidity and health, including: • noncommunicable diseases • psychosis • sepsis • health functioning • sexual health • qualitative studies of maternal morbidity. Participants held discussions on the reviews and described plans for future publications. Additionally, the group addressed plans for future work and systematic reviews needed on maternal morbidity, including on haemoglobinopathies (e.g. malaria, sickle cell) and mental health conditions. In December 2015, a manuscript on sexual health and maternal morbidity was published in BMC Pregnancy and Childbirth(30). Thematic areas 57 (b) Developing and testing a morbidity assessment tool: implementation of a pilot study to test a set of maternal morbidity measurement tools in three pilot sites This pilot study, which was completed at the end of December 2015, was implemented in Jamaica, Kenya and Malawi. The goal was to compare the types of morbidities women experienced between and across settings, and to determine the feasibility, acceptability and utility of using a modified, streamlined tool for routine measurement and summary estimates of morbidity to inform resource allocation and service provision. In each setting, approximately 250 women receiving ANC (at least 28 weeks pregnant) and 250 women receiving postpartum care (at least 6 weeks postpartum) were interviewed using the tool. In 2015, a manuscript outlining the methodology for the maternal morbidity classification criteria, upon which the measurement tool is based was accepted for publication in BMC Pregnancy and Childbirth (31). Planned activities • Data cleaning and analysis began in 2015 and will continue in early 2016. The data from the pilot sites are being uploaded, checked and cleaned in Geneva in real time. Preliminary analyses are currently being run to determine the tool’s utility. • At a principal investigators (PIs) meeting in Geneva on 19–20 January 2016, PIs and their co-PIs will gather to review preliminary pilot results by country and discuss implications. Participants will also prepare for dissemination of the results to the MMWG and stakeholders later in 2016. Additionally, PIs will discuss possible maternal morbidity indicators based on data and brainstorming for future work on a maternal morbidity measurement tool kit. • The pilot study protocol will be submitted to a peer-reviewed journal for wider dissemination in the maternal health community and to other relevant stakeholders. • A meeting of MMWG will be held in the second quarter of 2016. Participants will meet to address pending project deliverables, especially maternal morbidity indicators, and to set the future work agenda for maternal morbidity measurement. 126.96.36.199 Second stage of labour (i) The Gentle Assisted Pushing Study: a multicentre RCT of gentle assisted pushing (GAP) in the upright posture to reduce prolonged second stage of labour Fundal pressure (pushing on the upper part of the uterus in the direction of the birth canal) is often applied in routine practice. However, the benefits of and indications for its use are unclear and vigorous pressure is potentially harmful. There is some evidence that it may be applied routinely or to expedite delivery in some situations (e.g. fetal distress or maternal exhaustion), particularly in settings where other methods of achieving delivery (i.e. forceps, vacuum) are not available. Gentle assisted pushing (GAP) is an innovative method of applying gentle but steady pressure to the uterine fundus with the woman in an upright posture. This multicentre, unblinded RCT with three parallel arms (1:1:1) will randomize 1145 women at three hospitals in South Africa. The trial will evaluate the effects of GAP in an upright posture, or upright posture alone compared with routine (supine) posture (control), on reducing the mean time of delivery and the associated maternal and neonatal complications in women not having delivered within 15–30 minutes of entering the second stage of labour. Annual Technical Report 201558 Progress The study protocol was given final approval by the Research Project Review Panel (RP2) and WHO’s Ethics Review Committee (WHO-ERC) in late 2014, with data collection commencing in March 2015. Recruitment was initially slow but has improved substantially, with 20% of the sample size achieved. Planned activities • Recruitment will be concluded by end of 2016, with data analysis and submission for publication in early 2017. (ii) Safety and feasibility study of the Odon device for assisted vaginal delivery The aim of this study is to test the safety and feasibility of the Odon device to assist the delivery of the fetus during prolonged second stage of labour. In the context of the study with a total expected recruitment of 150 women and their babies, the device has been tested to date for safety and feasibility in 48 women undergoing normal delivery in a private hospital in Buenos Aires, Argentina. So far, two enrolment periods – between February 2011 and September 2012 with a one-year follow-up, and between February and December 2014 – have taken place. Becton, Dickinson and Company (BD) acquired the license of the Odon device in 2013 and is currently conducting preclinical and clinical studies and finalizing development of a new prototype. Recruitment is currently paused and will resume in mid-2016 when the new BD Odon device prototype is available in sufficient numbers. It was judged of high importance to consult an external and independent group of experts about testing a new improved version of the device and how this might affect the results of the study. Progress Results from the first period of the study were critical in informing device development and improvements of the device prototype under development by BD. The experience also suggests that the device is easy to use and allows successful expulsion of the fetal head. The Argentinian team also gained experience in training public hospital doctors who will join the study. These training sessions included training and certification using simulators and allowed good rates of skills acquisition; this experience will be used as a basis for the training of obstetricians/gynaecologists. The WHO RHR Department appointed a new Independent Advisory Board Committee (ISAC) and a new Data Safety and Monitoring Board (DSMB). These committees will advise WHO on decisions about the research plan and safety of the device. The first meetings of DSMB and ISAC were held in May 2015. The DSMB did not identify any serious safety issues and recommended continuation of the trial based on this interim analysis. The ISAC made recommendations to modify the trial population of women with non-emergency and normal delivery conditions to women presenting with some degree of prolonged second stage of labour, as will be defined by a new amended protocol. The Committee also agreed with the expansion of the study to public hospitals in Argentina, Kenya and South Africa. Planned activities • Contingent on positive results of BD’s preclinical and clinical studies, the Department will resume recruitment in public hospitals in Argentina, Kenya and South Africa in mid-2016. In order to achieve a total sample of 150 women, the study will enrol an additional 102 women within six to eight months of resuming recruitment. Thematic areas 59 • Contingent on positive results on safety and feasibility, it will be appropriate to proceed with an RCT comparing the Odon device to forceps or vacuum extraction in women with prolonged second stage of labour. 188.8.131.52 Caesarean section (i) China Labour and Delivery Survey Acknowledging that mortality outcomes are not the only important indicators when assessing the optimal rate of caesarean section, and given the lack of a clear understanding of the complex web of causes governing the increase in caesarean section and the ecological consequences and effects of this, in 2015 the Department started working with collaborators in China on a study aiming at improving this understanding in one of the countries with the largest increase in caesarean section rates worldwide: China. The objectives of this study are (a) to describe the contemporary caesarean delivery situation in China, and identify the main contributors to the very high caesarean section rate; and (b) to describe the current situation of obstetric complications and perinatal outcomes. This is a multicentre, large-scale, cross-sectional, observational study to collect comprehensive labour and delivery information on 200 000 births in China. This study builds on the experience, procedures and instruments used in the two WHO surveys previously conducted by the Department: the WHO Global Survey on Maternal and Perinatal Health, and the WHO Multicountry Survey on Maternal and Newborn Health, which both achieved high visibility and impact. It will also serve as a case study for the utilization of the Robson Classification, whose implementation (according to the Department’s vision and strategy) is critical to understanding, monitoring and optimizing caesarean section rates at any level, but particularly at the health-care facility level. Progress In 2015, the study was approved by the RP2 and WHO-ERC, and the team enrolled 124 hospitals in the survey. Data collection started on 1 March 2015. By the end of August 2015, 18 000 delivery records from 78 hospitals had been submitted. The survey is expected to take two years. Planned activities • Data collection will continue in 2016. A Steering Committee meeting is planned for September 2016. 184.108.40.206 Obstetric fistula The Department jointly with EngenderHealth completed a multicentre RCT that compared shorter versus longer duration of catheterization following fistula repair surgery in eight African countries. Progress The results of this trial were published in The Lancet in July 2015 (32). They show that 7-day catheterization is non-inferior to 14-day catheterization in terms of incidence of fistula repair breakdown. This publication was followed by correspondence and an authors’ reply published in The Lancet in November 2015 that emphasized the importance of the results found in the trial for women with fistula as well as for the facilities that provide fistula services (33). During the World Health Assembly in May 2015, the Department participated in two fistula-related side events. The objective of these events was to advocate for ending fistula. Annual Technical Report 201560 Planned activities • The Department is planning to develop evidence-based guidelines on obstetric fistula using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach for appraising the quality of evidence and determining the strength of recommendations. For this, the group will conduct a systematic review in 2016 on duration of catheterization after fistula surgery and include the results of the above- mentioned trial. This would be the first WHO guideline in this domain. 220.127.116.11 Hypertensive disorders of pregnancy (i) Long-term calcium supplementation in women at high-risk of pre-eclampsia: a randomized placebo controlled trial: The Calcium and Pre-eclampsia (CAP) trial Calcium supplementation has been shown to reduce the severity of pre-eclampsia, and to reduce maternal morbidity and newborn mortality when supplementation starts at around mid-pregnancy, particularly in women with low calcium intake. A calcium dose of 500 mg (elemental) is included in the WHO Model List of Essential Medicines by the 19th Expert Committee on the Selection and Use of Essential Medicines (34), and current WHO guidelines issued in 2013 recommend 1.5–2.0 g daily elemental calcium supplementation in pregnant women from 20 weeks’ gestation until the end of the pregnancy (35). However, calcium supplementation in the second half of pregnancy may be too late to affect pre-eclamptic processes, and it has been proposed that further improvements in outcomes may be achieved by earlier supplementation. Consequently, in 2011 the Department engaged in a multicountry randomized, double-blind, placebo-controlled trial to assess if calcium supplementation before pregnancy and in the first half of pregnancy reduces the incidence of recurrent pre-eclampsia more effectively than supplementation starting at 20 weeks of gestation. If found effective, the groundwork will have been done for research and then implementation of food fortification programmes. Progress The trial started in 2011 and, as of September 2015, 2308 women have been screened; 1174 have been recruited and 422 participants have completed their pregnancies at sites in Argentina, South Africa and Zimbabwe. The sample size to be achieved is 1440 women and it is expected that the trial will successfully finish recruitment early in 2016; data collection should be complete by the end of 2016. The DSMB met in February 2015 and the fourth Steering Committee meeting was held in Johannesburg in March 2015. Planned activities • Recruitment will finish early in 2016, and the pool of women recruited will be followed up during 2016. Pregnancies and outcomes will be recorded until the end of 2016. (ii) Simplified Treatment for Eclampsia Prevention using Magnesium Sulfate (STEPMAG) Magnesium sulphate (MgSO4) is the drug of choice for treatment of women with pre- eclampsia and eclampsia. There is clear evidence that it reduces the risk of eclampsia by close to 50% and probably reduces the risk of death in women with pre-eclampsia. Administration of the currently recommended dosage regimens requires resources that are often not universally available in low-income settings where severe morbidity and Thematic areas 61 death relating to pre-eclampsia are most common. As part of WHO efforts to increase coverage relating to the use of magnesium sulphate as prophylaxis and treatment for eclampsia worldwide, a technical consultation was held in October 2013 to deliberate on how to generate an evidence base for an alternative, easier to use, but equally efficacious magnesium sulphate regimen. This consultation identified a clear need for a stepwise approach to establish the rationale and scientific basis for testing a simpler magnesium sulphate regimen. The Department has embarked on a number of converging research activities to justify the need for and the choice of a minimum dosage regimen of magnesium sulphate in preparation for a large-scale non-inferiority trial. Progress (a) STEPMAG preparatory systematic reviews As part of the STEPMAG trial preparatory activities, two systematic reviews have been completed and published in 2015: “A systematic review of non-randomized studies on the use of alternative regimens of magnesium sulphate for treatment of pre-eclampsia and eclampsia” in Acta Obstetricia et Gynecologica(36); and “Clinical pharmacokinetic properties of magnesium sulphate in women with pre-eclampsia and eclampsia: a systematic review” in BJOG (37). (b) Magnesium sulphate dose-finding exploratory study In order to improve the probability of success for the proposed WHO non-inferiority trial, the Department in collaboration with Merck is conducting a pharmacokinetic– pharmacodynamics (PK/PD) modelling and simulation study to find a minimum effective and simplified dosage regimen. The goal of such a model-based approach is to systematically assess various dosing regimens in order to identify one that will achieve both equivalent (non-inferior) efficacy while at the same time being more practical to implement. Three identified datasets and sources are from Stanford University (USA), Srinagarind and Siriraj Hospitals (Thailand) and Oxford University (United Kingdom). Approvals and legal documents have been finalized and agreed with these three institutions, paving the way for Merck to be able to receive and use existing datasets for the modelling work. The modelling team at Merck has started a stepwise use of the Stanford dataset of serum magnesium levels and health outcome data in women receiving MgSO4 for pre-eclampsia, to perform the population pharmacokinetic modelling. (c) Global clinical practice patterns in the use of magnesium sulphate for the prevention and treatment of eclampsia: a multi-country survey Although there are two recommended magnesium sulphate dosing regimens that are widely accepted, there has not been sufficient research to det
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